{ "FullStudy":{ "Rank":217699, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517984", "OrgStudyIdInfo":{ "OrgStudyId":"DAIT CTOT-09" }, "Organization":{ "OrgFullName":"National Institute of Allergy and Infectious Diseases (NIAID)", "OrgClass":"NIH" }, "BriefTitle":"Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation", "OfficialTitle":"Immune Monitoring and Calcineurin Inhibitor (CNI) Withdrawal in Low Risk Recipients of Kidney Transplantation" }, "StatusModule":{ "StatusVerifiedDate":"August 2017", "OverallStatus":"Terminated", "WhyStopped":"Absence of equipoise on the basis of predetermined stopping rules.", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 16, 2016", "ResultsFirstSubmitQCDate":"October 7, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"November 30, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 10, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 11, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass":"NIH" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Clinical Trials in Organ Transplantation", "CollaboratorClass":"NETWORK" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this research study will evaluate whether reducing immunosuppression can decrease some of these side effects while still preventing rejection of the kidney.", "DetailedDescription":"Kidney transplantation is a treatment option for people with kidney disease. However, there is still much to learn about how to best care for the transplanted kidney and keep it functioning for a long time. Transplant recipients take immunosuppression (anti-rejection) drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent the immune system from attacking the transplanted kidney. All anti-rejection medications have unwanted side effects. The purpose of this study is to evaluate the safety of slowly removing tacrolimus, a CNI." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Kidney Transplant Recipients" ] }, "KeywordList":{ "Keyword":[ "recipients of living-donor kidney allografts", "antithymocyte globulin (ATG) induction", "calcineurin inhibitors (CNIs)", "CNI withdrawal" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"52", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Tacrolimus (CNI) Withdrawal", "ArmGroupType":"Experimental", "ArmGroupDescription":"Subjects randomized (2:1) to tacrolimus (CNI) withdrawal.\n\nRecipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a standard immunosuppressive regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus.Subjects without any clinical acute rejection (AR) in the first 6 months, without borderline or acute rejection on the 6 month biopsy, and without donor-specific antibody (DSA) at anytime, including the 6 month test are randomized (2:1) to tacrolimus (CNI) withdrawal.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tacrolimus (CNI) Withdrawal", "Drug: Standard Immunosuppressive Therapy" ] } },{ "ArmGroupLabel":"Standard Immunosuppressive Therapy", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Subjects randomized to standard immunosuppressive therapy, without subsequent tacrolimus (CNI) withdrawal.\n\nRecipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a standard immunosuppressive regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus. Tacrolimus (CNI) withdrawal does not occur.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Standard Immunosuppressive Therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Tacrolimus (CNI) Withdrawal", "InterventionDescription":"Recipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus.\n\nSubjects without any clinical acute rejection (AR) in the first 6 months, without borderline or acute rejection on the 6 month biopsy, and without donor-specific antibody (DSA) at anytime, including the 6 month test will be randomized (2:1) to tacrolimus (CNI) withdrawal.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Tacrolimus (CNI) Withdrawal" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "ATG Induction,Tacrolimus (CNI), MMF and Prednisone, Followed by CNI Withdrawal", "rabbit antithymocyte globulin (RATG)", "Thymoglobulin®", "calcineurin inhibitor (CNI)", "mycophenolate mofetil", "CellCept®" ] } },{ "InterventionType":"Drug", "InterventionName":"Standard Immunosuppressive Therapy", "InterventionDescription":"Recipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Standard Immunosuppressive Therapy", "Tacrolimus (CNI) Withdrawal" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "ATG induction,Tacrolimus (CNI), MMF and Prednisone", "rabbit antithymocyte globulin (RATG)", "Thymoglobulin®", "calcineurin inhibitor (CNI)", "mycophenolate mofetil", "CellCept®" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization", "PrimaryOutcomeDescription":"The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.", "PrimaryOutcomeTimeFrame":"IF/TA scores on protocol biopsies obtained at 24 months post-randomization will be compared to those obtained at the time of implantation for this measurement." } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation", "SecondaryOutcomeDescription":"Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function", "SecondaryOutcomeTimeFrame":"6 months post-transplantation, 24 months post-transplantation" },{ "SecondaryOutcomeMeasure":"Incidence of Acute Rejection", "SecondaryOutcomeDescription":"Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the 'Randomized to Tacrolimus Withdrawal' group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events.", "SecondaryOutcomeTimeFrame":"6 to 18 months post-randomization" },{ "SecondaryOutcomeMeasure":"Allograft Survival Rate", "SecondaryOutcomeDescription":"Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study.", "SecondaryOutcomeTimeFrame":"6 to 18 months post-randomization" },{ "SecondaryOutcomeMeasure":"Participant Survival Rate", "SecondaryOutcomeDescription":"Number of participants who did not die within the course of this study.", "SecondaryOutcomeTimeFrame":"6 to 18 months post-transplantation" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With New Donor Specific Antibodies (DSAs)", "SecondaryOutcomeDescription":"Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.", "SecondaryOutcomeTimeFrame":"6 to 18 months post-randomization" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Donor-Specific Memory Using Elispot", "SecondaryOutcomeDescription":"This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.", "SecondaryOutcomeTimeFrame":"6 to 18 months post-randomization" },{ "SecondaryOutcomeMeasure":"Percentage of Participants in the Experimental Arm Off Tacrolimus", "SecondaryOutcomeDescription":"Participants in the 'Randomized to Tacrolimus Withdrawal' group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies.", "SecondaryOutcomeTimeFrame":"18 months post-randomization" },{ "SecondaryOutcomeMeasure":"Incremental Change in IF/TA Scores", "SecondaryOutcomeDescription":"This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.", "SecondaryOutcomeTimeFrame":"6 to 18 months post-transplant" },{ "SecondaryOutcomeMeasure":"Measurement of Urinary Parameters Before and After Randomization", "SecondaryOutcomeDescription":"This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.", "SecondaryOutcomeTimeFrame":"6 months post-transplantation to 18 months post-randomization" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"INCLUSION CRITERIA -\n\nInitial Enrollment/Screening: Patients who meet all of the following criteria are eligible for enrollment as study subjects:\n\nSubject must be able to understand and provide written informed consent;\nPrimary living-donor (related or unrelated) kidney transplant recipients;\nPeak flow-based PRAs for class I and class II <30%(performed by local center);\nCurrent (within 8 weeks prior to transplantation) flow-based PRAs for class I and class II <30% (performed by local center);\nNo donor specific antibody by flow solid phase method on the peak PRA serum (if serum available), or on the current PRA serum (within 8 weeks prior to transplantation) performed by central core laboratory. If the sera for the peak PRA is not available, then only the current PRA serum will be tested;\nNegative T-cell and B-cell crossmatch by flow cytometry (performed by local center);\nFemale subjects of childbearing potential must have a negative pregnancy test (urine or serum) upon study entry;\nFemale and male subjects with reproductive potential must agree to use FDA approved methods of birth control while participating in the study.\n\nInclusion Criteria for Randomization:\n\nParticipants who meet all of the following criteria are eligible for randomization:\n\nNo history of acute rejection episodes;\nThe pre-randomization protocol biopsy should confirm no rejection, including borderline rejection (based on the central pathology read);\nNo donor specific antibody as detected by flow solid phase method (performed by the central core laboratory).\n\nEXCLUSION CRITERIA -\n\nInitial Enrollment/Screening:\n\nParticipants who meet any of these criteria are not eligible for enrollment as study subjects:\n\nRecipient of multiple organ transplants;\nPrior history of organ transplantation;\nDeceased-donor source;\nAny condition that would preclude protocol biopsies;\nHLA identical recipients;\nCurrently breast-feeding or plans to become pregnant during the timeframe of the study follow up period;\nAny condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements;\nInability or unwillingness to comply with study protocol;\nUse of investigational drugs within 4 weeks of study entry and for the duration of the study;\nRecent recipient of any licensed or investigational live attenuated vaccine(s) within two months of prior to study entry.\n\nExclusion Criteria for Randomization:\n\nParticipants who meet any of these criteria are not eligible for randomization:\n\nSubjects who receive less than 4.5mg/kg of Rabbit ATG (Thymoglobulin®) induction therapy;\nSubjects who test positive for BKV by PCR in the blood at 6 months post-transplant;\nAny condition that would preclude protocol biopsies;\nCurrently breast-feeding or plans to become pregnant during the timeframe of the study follow up period;\nAny condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements;\nInability or unwillingness of a subject to give written informed consent or comply with study protocol;\nUse of investigational drugs within 4 weeks of study entry and for the duration of the study;\nSubjects who receive less than 1500 mg daily of Mycophenolate Mofetil (CellCept®) or equivalent.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Donald Hricik, MD", "OverallOfficialAffiliation":"University Hospitals Cleveland Medical Center", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Peter S. Heeger, MD", "OverallOfficialAffiliation":"Icahn School of Medicine at Mount Sinai", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of California Los Angeles", "LocationCity":"Los Angeles", "LocationState":"California", "LocationZip":"90055", "LocationCountry":"United States" },{ "LocationFacility":"Yale University School of Medicine", "LocationCity":"New Haven", "LocationState":"Connecticut", "LocationZip":"06520-8029", "LocationCountry":"United States" },{ "LocationFacility":"Brigham & Women's Hospital", "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationZip":"02115", "LocationCountry":"United States" },{ "LocationFacility":"University of Michigan Hospital", "LocationCity":"Ann Arbor", "LocationState":"Michigan", "LocationZip":"48109", "LocationCountry":"United States" },{ "LocationFacility":"Washington University", "LocationCity":"Saint Louis", "LocationState":"Missouri", "LocationZip":"63110", "LocationCountry":"United States" },{ "LocationFacility":"Mount Sinai School of Medicine", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"10029", "LocationCountry":"United States" },{ "LocationFacility":"University Hospitals of Cleveland", "LocationCity":"Cleveland", "LocationState":"Ohio", "LocationZip":"44106-5048", "LocationCountry":"United States" },{ "LocationFacility":"Cleveland Clinic Foundation", "LocationCity":"Cleveland", "LocationState":"Ohio", "LocationZip":"44195", "LocationCountry":"United States" },{ "LocationFacility":"The Methodist Hospital", "LocationCity":"Houston", "LocationState":"Texas", "LocationZip":"77030", "LocationCountry":"United States" },{ "LocationFacility":"Health Sciences Centre", "LocationCity":"Winnipeg", "LocationState":"Manitoba", "LocationZip":"R3A IR9", "LocationCountry":"Canada" },{ "LocationFacility":"Toronto General Hospital", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M5G 2M1", "LocationCountry":"Canada" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25925687", "ReferenceType":"result", "ReferenceCitation":"Hricik DE, Formica RN, Nickerson P, Rush D, Fairchild RL, Poggio ED, Gibson IW, Wiebe C, Tinckam K, Bunnapradist S, Samaniego-Picota M, Brennan DC, Schröppel B, Gaber O, Armstrong B, Ikle D, Diop H, Bridges ND, Heeger PS; Clinical Trials in Organ Transplantation-09 Consortium. Adverse Outcomes of Tacrolimus Withdrawal in Immune-Quiescent Kidney Transplant Recipients. J Am Soc Nephrol. 2015 Dec;26(12):3114-22. doi: 10.1681/ASN.2014121234. Epub 2015 Apr 29." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"National Institute of Allergy and Infectious Diseases (NIAID)", "SeeAlsoLinkURL":"https://www.niaid.nih.gov/" },{ "SeeAlsoLinkLabel":"Clinical Trials in Organ Transplantation (CTOT)", "SeeAlsoLinkURL":"https://www.ctotstudies.org/" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Enrolled, Not Transplanted", "FlowGroupDescription":"These participants were consented and enrolled into the study, but did receive a living-donor kidney allograft transplant as specified by the protocol." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Transplanted, Not Randomized", "FlowGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Randomized to Tacrolimus Withdrawal", "FlowGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Randomized to Control Group", "FlowGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"26" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"7" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"3" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"10" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"23" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"8" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Screen Failure", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Ineligible for randomization", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"14" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Intent-to-treat", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Transplanted, But Not Randomized", "BaselineGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Randomized to Tacrolimus Withdrawal", "BaselineGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Randomized to Control Group", "BaselineGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"26" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"14" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"7" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"47" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"54.8", "BaselineMeasurementSpread":"11.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"46.5", "BaselineMeasurementSpread":"14.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"44.9", "BaselineMeasurementSpread":"8.5" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"50.9", "BaselineMeasurementSpread":"12.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"12" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"35" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"3" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"4" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"22" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"39" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Canada", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" } ] } } ] } },{ "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"40" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"HLA mismatch", "BaselineMeasureDescription":"Human leukocyte antigen (HLA) is a protein – or marker – found on most cells in your body and is used to match you with a donor for your bone marrow or cord blood transplant. The best transplant outcome happens when a patient’s HLA and donor’s HLA closely match. There are at least 8 HLA markers that are typically compared prior to transplantation. A mismatch of greater than three indicates that there is a potential for a poorer outcome than a better HLA match between donor and recipient.", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Number of HLA marker mismatches", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3.6", "BaselineMeasurementSpread":"1.7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3.4", "BaselineMeasurementSpread":"1.3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3.4", "BaselineMeasurementSpread":"1.3" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"3.4", "BaselineMeasurementSpread":"1.4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"CMV status (donor, recipient)", "BaselineMeasureDescription":"Cytomegalovirus (CMV) is a common virus, and is a concern when a person has a weakened immune system, such as during transplantation. Once infected with CMV, your body retains the virus for life. CMV can spread from donor to recipient during transplant and dormant CMV in the recipient could become active following transplantation due to weakened immune system. CMV positive recipients have a higher likelihood for incidence of CMV disease and allograft loss.", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Donor +, Recipient +", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"13" } ] } } ] } },{ "BaselineClassTitle":"Donor +, Recipient -", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"8" } ] } } ] } },{ "BaselineClassTitle":"Donor -, Recipient +", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" } ] } } ] } },{ "BaselineClassTitle":"Donor -, Recipient -", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"17" } ] } } ] } },{ "BaselineClassTitle":"Donor not done, Recipient +", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Donor missing, Recipient -", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization", "OutcomeMeasureDescription":"The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.", "OutcomeMeasurePopulationDescription":"No analyses were performed due to early study closure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"IF/TA scores on protocol biopsies obtained at 24 months post-randomization will be compared to those obtained at the time of implantation for this measurement.", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation", "OutcomeMeasureDescription":"Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function", "OutcomeMeasurePopulationDescription":"Intent-to-treat", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mL/min", "OutcomeMeasureTimeFrame":"6 months post-transplantation, 24 months post-transplantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"6 Month eGFR", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"56.2", "OutcomeMeasurementSpread":"13.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"62.3", "OutcomeMeasurementSpread":"15.0" } ] } } ] } },{ "OutcomeClassTitle":"24 Month eGFR", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"61.7", "OutcomeMeasurementSpread":"14.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"68.6", "OutcomeMeasurementSpread":"24.1" } ] } } ] } },{ "OutcomeClassTitle":"Change in eGFR from 6 to 24 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.5", "OutcomeMeasurementSpread":"12.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.3", "OutcomeMeasurementSpread":"12.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Incidence of Acute Rejection", "OutcomeMeasureDescription":"Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the 'Randomized to Tacrolimus Withdrawal' group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events.", "OutcomeMeasurePopulationDescription":"Intent-to-treat", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"6 to 18 months post-randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Allograft Survival Rate", "OutcomeMeasureDescription":"Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study.", "OutcomeMeasurePopulationDescription":"Intent-to-treat", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"6 to 18 months post-randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Participant Survival Rate", "OutcomeMeasureDescription":"Number of participants who did not die within the course of this study.", "OutcomeMeasurePopulationDescription":"Intent-to-treat", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"6 to 18 months post-transplantation", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With New Donor Specific Antibodies (DSAs)", "OutcomeMeasureDescription":"Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.", "OutcomeMeasurePopulationDescription":"Intent-to-treat", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"6 to 18 months post-randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Donor-Specific Memory Using Elispot", "OutcomeMeasureDescription":"This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.", "OutcomeMeasurePopulationDescription":"No analyses were performed due to early study closure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"6 to 18 months post-randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants in the Experimental Arm Off Tacrolimus", "OutcomeMeasureDescription":"Participants in the 'Randomized to Tacrolimus Withdrawal' group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies.", "OutcomeMeasurePopulationDescription":"Intent-to-treat", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"18 months post-randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"43" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Incremental Change in IF/TA Scores", "OutcomeMeasureDescription":"This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.", "OutcomeMeasurePopulationDescription":"No analyses were performed due to early study closure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"6 to 18 months post-transplant", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Measurement of Urinary Parameters Before and After Randomization", "OutcomeMeasureDescription":"This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.", "OutcomeMeasurePopulationDescription":"No analyses were performed due to early study closure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"6 months post-transplantation to 18 months post-randomization", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Randomized to Tacrolimus Withdrawal", "OutcomeGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Randomized to Control Group", "OutcomeGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Transplantation through end of study (up to 24 months)", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Transplanted, But Not Randomized", "EventGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"26", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"26" },{ "EventGroupId":"EG001", "EventGroupTitle":"Randomized to Tacrolimus Withdrawal", "EventGroupDescription":"These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.", "EventGroupSeriousNumAffected":"4", "EventGroupSeriousNumAtRisk":"14", "EventGroupOtherNumAffected":"5", "EventGroupOtherNumAtRisk":"14" },{ "EventGroupId":"EG002", "EventGroupTitle":"Randomized to Control Group", "EventGroupDescription":"Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"7", "EventGroupOtherNumAffected":"2", "EventGroupOtherNumAtRisk":"7" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Transplant rejection", "SeriousEventOrganSystem":"Immune system disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"7" } ] } },{ "SeriousEventTerm":"Cellulitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"7" } ] } },{ "SeriousEventTerm":"Pneumonia legionella", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"7" } ] } },{ "SeriousEventTerm":"Respiratory tract infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"7" } ] } },{ "SeriousEventTerm":"Staphylococcal infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"7" } ] } },{ "SeriousEventTerm":"Post procedural haematoma", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"26" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"14" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"7" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Leukopenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Neutropenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Hernia obstructive", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Transplant rejection", "OtherEventOrganSystem":"Immune system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"BK virus infection", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Cytomegalovirus infection", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Influenza", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Glucose tolerance impaired", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Osteopenia", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Osteoporosis", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Haematuria", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Asthma", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Alopecia", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"7" } ] } },{ "OtherEventTerm":"Rash maculo-papular", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"26" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"14" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"7" } ] } } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Director, Clinical Research Operations Program", "PointOfContactOrganization":"DAIT/NIAID", "PointOfContactEMail":"DAITClinicalTrialsGov@niaid.nih.gov", "PointOfContactPhone":"301-594-7669" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000009173", "InterventionMeshTerm":"Mycophenolic Acid" },{ "InterventionMeshId":"D000011241", "InterventionMeshTerm":"Prednisone" },{ "InterventionMeshId":"D000016559", "InterventionMeshTerm":"Tacrolimus" },{ "InterventionMeshId":"C000512542", "InterventionMeshTerm":"Thymoglobulin" },{ "InterventionMeshId":"D000000961", "InterventionMeshTerm":"Antilymphocyte Serum" },{ "InterventionMeshId":"D000007166", "InterventionMeshTerm":"Immunosuppressive Agents" },{ "InterventionMeshId":"D000065095", "InterventionMeshTerm":"Calcineurin Inhibitors" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000893", 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"InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" } ] } } } } } }