Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT00189202
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aojo@umich.edu', 'phone': '734 9364890', 'title': 'Dr. Akinlolu Ojo, Professor of Medicine', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year follow up', 'eventGroups': [{'id': 'EG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative One-year Acute Rejection Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000'], 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence margin 8% plus or minus 4.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'One-year Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000'], 'statisticalMethod': 'Kaplan-Meier', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'One-year Patient Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Post Transplant Diabetes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Drug-treated Dyslipidemic Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sirolimus, Steroid Avoidance Arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.\n\nSirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'spread': '13.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'From the 49 consented, 5 were not begun on treatment or removed very early on for clinical reasons, so they are not included in baseline data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2008-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2017-02-20', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-20', 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative One-year Acute Rejection Rates', 'timeFrame': '12 months', 'description': 'To test the efficacy of Sirolimus (SRL)-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: cumulative one-year acute rejection rates of the transplant'}, {'measure': 'One-year Graft Survival', 'timeFrame': '12 months', 'description': 'To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year graft survival'}, {'measure': 'One-year Patient Survival', 'timeFrame': '12 months', 'description': 'To test the efficacy of SRL-based steroid avoidance regimen in high risk de novo renal allograft recipients. Efficacy endpoints for this objective is: one-year patient survival'}], 'secondaryOutcomes': [{'measure': 'Incidence of Post Transplant Diabetes', 'timeFrame': '12 months', 'description': 'To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is incidence of posttransplant diabetes mellitus'}, {'measure': 'Drug-treated Dyslipidemic Syndrome', 'timeFrame': '12 months', 'description': 'To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is drug-treated dyslipidemic syndrome'}, {'measure': 'Blood Pressure Control', 'timeFrame': '12 months', 'description': 'To determine whether SRL-based steroid avoidance maintenance regimen is associated with decreased rates of metabolic complications. Endpoint is number of people who had their blood pressure in the target control range with or without medication'}]}, 'conditionsModule': {'conditions': ['End Stage Renal Disease', 'Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.\n\nThis study will evaluate:\n\n1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,\n2. Decreased rates of metabolic complications such as post-transplant diabetes,\n3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.', 'detailedDescription': 'This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American recipient race\n* Solitary cadaveric or living donor renal transplantation\n* Age ≥18years at the time of transplantation\n* Negative pregnancy serum test in females with childbearing potential\n\nExclusion Criteria:\n\n* Age \\< 18 years at the time of transplantation\n* Multi-organ transplant recipient\n* Currently taking steroids\n* White Blood Cell Count \\< 3,000\n* Platelet count \\< 100,000\n* Triglycerides \\>400mg/dL\n* Cholesterol \\> 350 mg/dL\n* Unwillingness to comply with study procedures\n* Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)'}, 'identificationModule': {'nctId': 'NCT00189202', 'briefTitle': 'Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Efficacy of Sirolimus-Based, Steroid Avoidance Maintenance Immunosuppression in Black de Novo Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'Steroid Avoidance in A.A.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sirolimus, steroid avoidance arm', 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid.', 'interventionNames': ['Drug: Sirolimus']}], 'interventions': [{'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamune'], 'description': 'Thymoglobulin induction, sirolimus and no maintenance corticosteroid', 'armGroupLabels': ['Sirolimus, steroid avoidance arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Akinlolu Ojo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emeritus Professor of Medicine', 'investigatorFullName': 'Akinlolu Ojo', 'investigatorAffiliation': 'University of Michigan'}}}}