Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 12:26 PM
Study NCT ID:
NCT00784966
Status:
WITHDRAWN
Last Update Posted:
2014-09-16
First Post:
2008-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Islet After Kidney Transplant for Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'University decision.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-12', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.', 'timeFrame': 'Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.'}], 'secondaryOutcomes': [{'measure': 'Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.', 'timeFrame': 'Outcome measures will be assessed at protocol prescribed intervals.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Islet transplantation', 'Type 1 Diabetes Mellitus', 'Kidney Transplantation'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.\n\nExclusion Criteria:\n\n* Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)\n* Active infections (clinically or by laboratory testing)\n* History of current malignancy or suspicion of malignancy until properly investigated and excluded\n* Liver or biliary abnormalities\n* Unstable cardiovascular disease\n* Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception'}, 'identificationModule': {'nctId': 'NCT00784966', 'briefTitle': 'Islet After Kidney Transplant for Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'VCU IRB 4196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Two weeks etanercept post islet transplant', 'interventionNames': ['Drug: etanercept']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Two months etanercept treatment post islet transplant', 'interventionNames': ['Drug: etanercept']}], 'interventions': [{'name': 'etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': "Treatment option 'A'-Two weeks treatment with etanercept. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two weeks.", 'armGroupLabels': ['1']}, {'name': 'etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': 'Etanercept will be given for a total of 2 months. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two months.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Health System', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Adrian H Cotterell, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University Health System'}, {'name': 'John N Clore, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Miami', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}