Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-04 @ 9:58 AM
Study NCT ID:
NCT01442402
Status:
TERMINATED
Last Update Posted:
2021-01-27
First Post:
2011-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APOL1 Gene Variants in African American Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'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': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Aims 1 and 2:\n\nSubjects will collect a saliva specimen in an Oragene®•DNA sample collection kit for genotyping. We will also collected any discarded (no longer utilized for clinical purposes) tissue from biopsies.\n\nAim 3:\n\nPrior to transplant, subjects will collect saliva in an Oragene®•DNA sample collection kit for genotyping and 10cc of blood will be drawn into a Na heparin collection tube for APOL1 protein analysis. When applicable, plasmapheresis effluent will be collected. We will also collected any discarded (no longer utilized for clinical purposes)tissue from biopsies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'whyStopped': 'Lack of funding/resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2011-09-27', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Allograft survival', 'timeFrame': 'year 1, 3, 5'}], 'secondaryOutcomes': [{'measure': 'Allograft function as measured by serum creatinine', 'timeFrame': 'creatinine levels at year-1, year-3 and year-5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Transplant;Failure,Kidney', 'Kidney Disease', 'Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'Aim 1:\n\nDetermine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans\n\nAim 2:\n\nDetermine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease\n\nAim 3:\n\nInvestigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'African American Renal Transplant Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Aim 1:\n\nInclusion Criteria:\n\n* self-reported African American\n* 18 years or older\n* kidney transplant within 12 years\n\nAim 2:\n\nInclusion Criteria for patients with recurrent disease:\n\n* self-reported African American\n* 18 years or older\n* kidney transplant within 12 years\n* recurrent or de novo glomerular disease on allograft kidney biopsy\n\nInclusion Criteria for control group:\n\n* self-reported African American\n* 18 years or older\n* kidney transplant within 12 years\n* end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy\n\nExclusion Criteria for control group:\n\n* clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine \\>2)\n\nAim 3:\n\nInclusion Criteria:\n\n* self-reported African American\n* 18 years or older\n* scheduled living kidney transplant'}, 'identificationModule': {'nctId': 'NCT01442402', 'briefTitle': 'APOL1 Gene Variants in African American Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms', 'orgStudyIdInfo': {'id': '2011P000734'}}, 'armsInterventionsModule': {'armGroups': [{'label': '2 APOL1 genotypes', 'description': 'African American transplant recipients with homozygous APOL1 gene variants'}, {'label': '0 or 1 APOL1 genotypes', 'description': 'African American transplant recipients without homozygous APOL1 gene variants'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anil K Chandraker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director of Renal Transplantation', 'investigatorFullName': 'Anil K. Chandraker, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}