{
  "FullStudy":{
    "Rank":217838,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516177",
          "OrgStudyIdInfo":{
            "OrgStudyId":"DAIT ITN524ST/CTOT-12"
          },
          "Organization":{
            "OrgFullName":"National Institute of Allergy and Infectious Diseases (NIAID)",
            "OrgClass":"NIH"
          },
          "BriefTitle":"Associating Renal Transplantation With the ITN Signature of Tolerance",
          "OfficialTitle":"An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)",
          "Acronym":"ARTIST"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 16, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 20, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"National Institute of Allergy and Infectious Diseases (NIAID)",
            "LeadSponsorClass":"NIH"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Immune Tolerance Network (ITN)",
                "CollaboratorClass":"NETWORK"
              },{
                "CollaboratorName":"Clinical Trials in Organ Transplantation",
                "CollaboratorClass":"NETWORK"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression. The study goal is to find out how common this pattern is in transplant patients, as a first step in determining if it can be used to personalize anti-rejection drug regimens better.",
          "DetailedDescription":"Following surgery, kidney transplant patients must take medications in order to prevent rejection of their transplanted organ. These medications can be very effective. Called immunosuppressive drugs, they work by reducing the activity of the immune system. Because of this, however, they can also have serious side effects, including increased risks of serious infections and certain types of cancer.\n\nThe ITN Registry of Tolerant Kidney Transplant Recipients recently identified a rare group of people whose immune system has accepted their transplant without continued use of immunosuppressive drugs. Researchers have found that these patients have a unique pattern of cells and genes expressed in their blood compared to other transplant patients.\n\nThe ARTIST study will ask the questions \"Are there other transplant patients who show this pattern?\" and \"If so, how often?\"\n\nThe goal is to find out if there are other transplant patients who are taking immunosuppression who also show this pattern of genes. If there are others, then this pattern may one day be useful in identifying transplant patients who could reduce the dose of immunosuppression they need without fear of rejection.\n\nResearchers are seeking adults who have received a kidney transplant within the past 1 to 5 years. Participants will be asked to attend 3 short appointments with study doctors over a period of 2 years. At these visits, doctors will request demographic and clinical information, relevant medical histories and blood and urine samples. Participants will be compensated for their time.\n\nIt is important to note that this is an observational study only. Other than receiving consultations and advice from the transplant team, there is no direct medical benefit to participating. However, by participating, patients may play an active part in helping doctors learn to control kidney transplant rejection more effectively, with fewer drugs."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Kidney Transplantation"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Kidney Transplantation",
              "kidney transplant",
              "renal transplant",
              "immunosuppression"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Whole blood Isolation PBMC isolated RNA specimens"
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"250",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Renal Transplant Recipients",
                "ArmGroupDescription":"Subjects who received a kidney transplant within the past 1 to 5 years"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"The presence of at least one time point of the previously identified renal transplant tolerance signature.",
                "PrimaryOutcomeTimeFrame":"2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype",
                "SecondaryOutcomeTimeFrame":"2 years"
              },{
                "SecondaryOutcomeMeasure":"Selected clinical events and laboratory parameters to assess hematologic and renal function",
                "SecondaryOutcomeTimeFrame":"2 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nReceived first kidney transplant from a living or deceased donor.\nKidney transplanted between 1 and 5 years ago.\nCalculated GFR of greater than or equal to 45 mL/min/1.73 m2 within last 6 months\nAbility to understand and provide informed consent.\n\nExclusion Criteria:\n\nHistory of steroid-resistant acute rejection\nHistory of two or more episodes of acute rejection\nAny acute rejection in the past year\nCurrent malignancy\nTransplant of another organ\nAIDS according to the CDC definition of AIDS.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"The study will include 250 participants who are determined to be eligible for further follow-up based on the eligibility criteria.\n\nAmong those eligible for further follow-up\n\nat least 25 participants will be renal transplant recipients who received induction therapy with Campath, and\nat least 25 participants will be renal transplant recipients who are receiving sirolimus or everolimus at time of enrollment and who have not received calcineurin inhibitors for at least 30 days prior to enrollment",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Anil Chandraker, MD",
                "OverallOfficialAffiliation":"Brigham and Women's Hospital",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Kenneth Newell, MD, PhD",
                "OverallOfficialAffiliation":"Emory University",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Laurence Turka, MD",
                "OverallOfficialAffiliation":"Beth Israel Deaconess Medical Center",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University of Alabama Birmingham",
                "LocationCity":"Birmingham",
                "LocationState":"Alabama",
                "LocationZip":"35294",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of California San Francisco",
                "LocationCity":"San Francisco",
                "LocationState":"California",
                "LocationZip":"94143",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Emory University",
                "LocationCity":"Atlanta",
                "LocationState":"Georgia",
                "LocationZip":"30322",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Northwestern University",
                "LocationCity":"Chicago",
                "LocationState":"Illinois",
                "LocationZip":"60611",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Beth Israel Deaconess Medical Center",
                "LocationCity":"Boston",
                "LocationState":"Massachusetts",
                "LocationZip":"02115",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Brigham and Women's Hospital",
                "LocationCity":"Boston",
                "LocationState":"Massachusetts",
                "LocationZip":"02115",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Mount Sinai School of Medicine",
                "LocationCity":"New York",
                "LocationState":"New York",
                "LocationZip":"10029",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"The Cleveland Clinic Foundation",
                "LocationCity":"Cleveland",
                "LocationState":"Ohio",
                "LocationZip":"44195",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"20501946",
                "ReferenceType":"background",
                "ReferenceCitation":"Newell KA, Asare A, Kirk AD, Gisler TD, Bourcier K, Suthanthiran M, Burlingham WJ, Marks WH, Sanz I, Lechler RI, Hernandez-Fuentes MP, Turka LA, Seyfert-Margolis VL; Immune Tolerance Network ST507 Study Group. Identification of a B cell signature associated with renal transplant tolerance in humans. J Clin Invest. 2010 Jun;120(6):1836-47. doi: 10.1172/JCI39933. Epub 2010 May 24."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"National Institute of Allergy and Infectious Diseases (NIAID) website",
                "SeeAlsoLinkURL":"https://www.niaid.nih.gov/"
              },{
                "SeeAlsoLinkLabel":"Immune Tolerance Network website",
                "SeeAlsoLinkURL":"http://www.immunetolerance.org"
              },{
                "SeeAlsoLinkLabel":"Clinical Trials in Organ Transplantation website",
                "SeeAlsoLinkURL":"https://www.ctotstudies.org/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}