{ "FullStudy":{ "Rank":217549, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519947", "OrgStudyIdInfo":{ "OrgStudyId":"ML25754" }, "Organization":{ "OrgFullName":"Hoffmann-La Roche", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis", "OfficialTitle":"Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients", "Acronym":"ALTITUD" }, "StatusModule":{ "StatusVerifiedDate":"June 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 30, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 30, 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 30, 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"September 8, 2017", "ResultsFirstSubmitQCDate":"June 13, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"December 27, 2018", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"June 17, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 19, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Hoffmann-La Roche", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "IsFDARegulatedDrug":"No", "IsFDARegulatedDevice":"No" }, "DescriptionModule":{ "BriefSummary":"This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Anemia, Kidney Disease, Chronic" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"87", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Pre-dialysis, sea level", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Participants received 50-250 mcg SC according to local label.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Methoxy polyethylene glycol-epoetin beta" ] } },{ "ArmGroupLabel":"Dialysis, sea level", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Participants received 50-250 mcg SC according to local label.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Methoxy polyethylene glycol-epoetin beta" ] } },{ "ArmGroupLabel":"Pre-dialysis, >1800 meters", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants received 50-250 mcg SC according to local label.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Methoxy polyethylene glycol-epoetin beta" ] } },{ "ArmGroupLabel":"Dialysis, >1800 meters", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants received 50-250 mcg SC according to local label.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Methoxy polyethylene glycol-epoetin beta" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Methoxy polyethylene glycol-epoetin beta", "InterventionDescription":"Participants received 50-250 mcg SC according to local label", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Dialysis, >1800 meters", "Dialysis, sea level", "Pre-dialysis, >1800 meters", "Pre-dialysis, sea level" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Mircera" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL", "PrimaryOutcomeTimeFrame":"Up to approximately 20 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in Hemoglobin Concentration", "SecondaryOutcomeTimeFrame":"From baseline to 6 months" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment", "SecondaryOutcomeTimeFrame":"3 and 6 months" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Adverse Events", "SecondaryOutcomeDescription":"An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.", "SecondaryOutcomeTimeFrame":"Up to approximately 20 months" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Requiring Dose Adjustments", "SecondaryOutcomeDescription":"This outcome measure was not assessed.", "SecondaryOutcomeTimeFrame":"Up to approximately 20 months" },{ "SecondaryOutcomeMeasure":"Incidence of Red Blood Cell Transfusions", "SecondaryOutcomeDescription":"This outcome measure was not assessed.", "SecondaryOutcomeTimeFrame":"Up to approximately 20 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAdult participants, >/= 18 years of age\nChronic kidney disease stage III-IV or V\nProbable start of dialysis within 18 months (pre-dialysis group)\nHemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group)\nAdequate iron status\nFemales of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug\n\nExclusion Criteria:\n\nFailing renal allograft in place\nAcute or chronic bleeding within 8 weeks prior to screening\nTransfusion of red blood cells within 8 weeks prior to screening\nPoorly controlled hypertension, defined as hypertension that needs hospitalization to obtain control\nHistory of seizures, hemoglobinopathies and/or severe liver disease\nActive malignant disease, except for non-melanoma skin cancer\nImmunosuppressive therapy in the 12 weeks prior to screening\nTreatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment\nKnown hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients\nPregnant or lactating women", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Clinical Trials", "OverallOfficialAffiliation":"Hoffmann-La Roche", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C", "LocationCity":"Aguascalientes", "LocationZip":"20210", "LocationCountry":"Mexico" },{ "LocationFacility":"Nefros Investigación S.C.", "LocationCity":"Delegación Coyoacan", "LocationZip":"CP. 04700", "LocationCountry":"Mexico" },{ "LocationFacility":"Centro de hemodialisis del norte S.C.", "LocationCity":"Mexicali", "LocationZip":"21100", "LocationCountry":"Mexico" },{ "LocationFacility":"Hospital Angeles Lindavista;Nefrologia", "LocationCity":"Mexico City", "LocationZip":"07760", "LocationCountry":"Mexico" },{ "LocationFacility":"Hospital Star Medica Morelia", "LocationCity":"Morelia", "LocationZip":"58070", "LocationCountry":"Mexico" },{ "LocationFacility":"Unidad De Dialisis La Loma S.C.", "LocationCity":"Pureto Vallarta", "LocationZip":"48333", "LocationCountry":"Mexico" },{ "LocationFacility":"Hospital Regional De Alta Especialidad De Veracruz; Nephrology", "LocationCity":"Veracruz", "LocationZip":"91700", "LocationCountry":"Mexico" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"87 participants were enrolled in the study. One participant did not receive study drug.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Pre-dialysis, Sea Level", "FlowGroupDescription":"Participants received 50-250 mcg subcutaneously (SC) according to local label." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Dialysis, Sea Level", "FlowGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Pre-dialysis, >1800 Meters", "FlowGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Dialysis, >1800 Meters", "FlowGroupDescription":"Participants received 50-250 mcg SC according to local label." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"19" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"11" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"42" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"17" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"8" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"34" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"8" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Peritoneal Dialysis Needed", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Development of Anemia", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Blood Transfusion", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Poor Response", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Pre-dialysis, Sea Level", "BaselineGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Dialysis, Sea Level", "BaselineGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Pre-dialysis, >1800 Meters", "BaselineGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Dialysis, >1800 Meters", "BaselineGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"19" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"10" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"42" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"86" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"60.7", "BaselineMeasurementSpread":"15.1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"38.5", "BaselineMeasurementSpread":"18.8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"61.7", "BaselineMeasurementSpread":"15.6" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"56.5", "BaselineMeasurementSpread":"17.4" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"56.2", "BaselineMeasurementSpread":"17.8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"23" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"48" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"38" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL", "OutcomeMeasurePopulationDescription":"The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"micrograms (mcg)", "OutcomeMeasureTimeFrame":"Up to approximately 20 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pre-dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pre-dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"10" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"42" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"150.3", "OutcomeMeasurementSpread":"69.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"194.7", "OutcomeMeasurementSpread":"214.2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"98.7", "OutcomeMeasurementSpread":"22.5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"66.6", "OutcomeMeasurementSpread":"33.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Hemoglobin Concentration", "OutcomeMeasurePopulationDescription":"The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure. Data are reported for evaluable participants.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"grams per deciliter (g/dL)", "OutcomeMeasureTimeFrame":"From baseline to 6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pre-dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pre-dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"3" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"8" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"34" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.4", "OutcomeMeasurementSpread":"0.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.5", "OutcomeMeasurementSpread":"1.5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementSpread":"0.8" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2.4", "OutcomeMeasurementSpread":"1.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment", "OutcomeMeasurePopulationDescription":"The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"3 and 6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pre-dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pre-dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"10" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"42" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"3 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"36.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"28.6" } ] } } ] } },{ "OutcomeClassTitle":"6 months", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"52.6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"13.3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"19.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Adverse Events", "OutcomeMeasureDescription":"An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.", "OutcomeMeasurePopulationDescription":"The safety population included all enrolled participants who received at least one dose of study drug and had a subsequent safety evaluation dose.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Up to approximately 20 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pre-dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pre-dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"19" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"10" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"42" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"84.2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"90.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"66.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"85.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Requiring Dose Adjustments", "OutcomeMeasureDescription":"This outcome measure was not assessed.", "OutcomeMeasurePopulationDescription":"Data were not collected.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"Up to approximately 20 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pre-dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Dialysis, Sea Level", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pre-dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Dialysis, >1800 Meters", "OutcomeGroupDescription":"Participants received 50-250 mcg SC according to local label." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"0" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"0" } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Incidence of Red Blood Cell Transfusions", "OutcomeMeasureDescription":"This outcome measure was not assessed.", "OutcomeMeasurePopulationDescription":"Data were not collected.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureTimeFrame":"Up to approximately 20 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pre-dialysis, Sea Level", "OutcomeGroupDescription":"Participants 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