Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT00409461
Status:
TERMINATED
Last Update Posted:
2006-12-11
First Post:
2006-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'lastUpdateSubmitDate': '2006-12-08', 'studyFirstSubmitDate': '2006-12-08', 'studyFirstSubmitQcDate': '2006-12-08', 'lastUpdatePostDateStruct': {'date': '2006-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-11', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Islet Transplantation', 'Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '18212631', 'type': 'DERIVED', 'citation': 'Gillard P, Ling Z, Mathieu C, Crenier L, Lannoo M, Maes B, Roep B, Gorus F, Pipeleers D, Keymeulen B. Comparison of sirolimus alone with sirolimus plus tacrolimus in type 1 diabetic recipients of cultured islet cell grafts. Transplantation. 2008 Jan 27;85(2):256-63. doi: 10.1097/TP.0b013e31815e8926.'}]}, 'descriptionModule': {'briefSummary': 'Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 insulin-dependent diabetic patients\n* C-peptide \\< 0.15 nmol/l (\\<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia \\> 180 mg/dl)\n* diabetic nephropathy\n* hypoglycaemic unawareness\n\nExclusion Criteria:\n\n* smoker before transplantation\n* plasma creatinine \\> 2 mg/dl\n* albuminuria \\>1000 mg/24 hrs\n* abnormal liver function\n* history of thrombosis or pulmonary embolism\n* history of malignancy, tuberculosis or chronic viral hepatitis\n* history of any other serious illness which could be relevant for the protocol\n* HLA antibodies\n* EBV antibody negative\n* HIV 1 \\& 2 antibody positive'}, 'identificationModule': {'nctId': 'NCT00409461', 'briefTitle': 'Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts', 'organization': {'class': 'OTHER', 'fullName': 'AZ-VUB'}, 'officialTitle': 'Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts', 'orgStudyIdInfo': {'id': '4-2001-434'}, 'secondaryIdInfos': [{'id': 'G.0375.00'}, {'id': 'G.0084.02'}, {'id': 'GOA/2004/10'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ATG-Sirolimus-Tacrolimus', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Academisch Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Bart Keymeulen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZ-VUB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ-VUB', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fund for Scientific Research, Flanders, Belgium', 'class': 'OTHER'}, {'name': 'Belgian Government', 'class': 'OTHER_GOV'}]}}}