Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00285233
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2006-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-31', 'studyFirstSubmitDate': '2006-01-30', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the incidence and severity of hypoglycemia in type 1 diabetic subjects receiving an islet allotransplant and immunotherapy during the first year posttransplant.', 'timeFrame': '1 year'}, {'measure': 'Assess liver laboratory tests during the first year following intraportal islet allotransplantation.', 'timeFrame': '1 yr'}, {'measure': 'Assess the incidence, type, and severity of islet transplant-related infectious complications during the first year posttransplant.', 'timeFrame': '1 year'}, {'measure': 'Assess the proportion of recipients who develop alloantibodies directed at donor alloantigens during the first year posttransplant.', 'timeFrame': '1 year'}, {'measure': 'Monitor the incidence, timing, and severity of adverse events as well as their relationship to the islet transplant procedure and additional protocol-regulated treatment products during the first year after islet transplantation.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Assess the proportion of type 1 diabetic subjects receiving delayed mycophenolate mofetil instead of tacrolimus who achieve insulin independence in the first year after transplantation of allogeneic islets.', 'timeFrame': '1 year'}, {'measure': 'Assess the proportion of type 1 diabetic islet allograft recipients with full and partial alloislet function at one year post transplant.', 'timeFrame': '1 year'}, {'measure': 'Assess the glycemic control, insulin secretory responses, and the glucose disposal rate during the first year posttransplant.', 'timeFrame': '1 year'}, {'measure': 'Effect of donor age, pretransplant islet insulin secretory response, # of transplanted islet equivalents, # of transplanted beta cells, pretransplant insulin action, recipient BMI and immunosuppressive therapy on safety and efficacy.', 'timeFrame': '1 year'}, {'measure': 'Assess, in a selected group of islet allotransplant recipients, the autoimmune and alloimmune responses to transplanted islets at intervals during the first year posttransplant.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes', 'Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '15713772', 'type': 'RESULT', 'citation': 'Hering BJ, Kandaswamy R, Ansite JD, Eckman PM, Nakano M, Sawada T, Matsumoto I, Ihm SH, Zhang HJ, Parkey J, Hunter DW, Sutherland DE. Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes. JAMA. 2005 Feb 16;293(7):830-5. doi: 10.1001/jama.293.7.830.'}], 'seeAlsoLinks': [{'url': 'http://www.diabetesinstitute.org', 'label': 'Diabetes Institute for Immunology and Transplantation - U of M'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the safety and efficacy of islet allotransplantation for the reestablishment of stable glycemic control in patients with type 1 diabetes, using anti-thymocyte globulin induction immunosuppression with sirolimus, mycophenolate mofetil and low dose tacrolimus maintenance immunosuppression.', 'detailedDescription': 'To assess the safety and efficacy of a new single-donor islet allotransplant protocol focusing on minimization of ischemic damage by the two-layer pancreas preservation technique, attenuation of posttransplant nonspecific inflammatory responses by etanercept and anti-thymocyte globulin, deletion/inactivation of autoreactive T cells by anti-thymocyte globulin and daclizumab induction immunotherapy, and potent yet non-diabetogenic maintenance immunosuppression with sirolimus and delayed mycophenolate mofetil instead of tacrolimus for the reestablishment of stable glycemic control in recipients with type 1 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary islet allotransplant\n2. Type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team:\n\n 1. Metabolic lability/instability;\n 2. Reduced awareness of hypoglycemia;\n 3. Persistently poor glucose control (as defined by HgbA1c\\>10% at the end of six months of intensive management efforts with the diabetes care team);\n 4. Progressive secondary complications.\n3. Age 18 and older\n4. Able to give written informed consent\n\nExclusion Criteria:\n\n1. Known hypersensitivity to rabbit proteins.\n2. Presence of history of panel-reactive anti-HLA antibodies (\\>10%).\n3. Insufficient cardiovascular reserve.\n4. Creatinine clearance \\<60 mL/min/m2.\n5. Portal hypertension, abnormal liver enzyme tests, or history of significant liver disease.\n6. History of malignancy within 5 years.\n7. Active peptic ulcer disease.\n8. Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications.\n9. Pregnancy or breast-feeding.\n10. Active infections.\n11. Serological evidence of infection with HIV, or HBsAg or HCVAb positive within the previous 12 months prior to transplantation.\n12. Negative screen for Epstein-Barr Virus (EBV) by an EBNA method\n13. Evidence of infiltrate, cavitation, or consolidation on chest x-ray during pre-study screening.\n14. Schizophrenia, bipolar disorder, or major depression that is unstable or uncontrolled on current medications.\n15. Ongoing substance abuse; drug or alcohol.\n16. Recent history of noncompliance.\n17. Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.'}, 'identificationModule': {'nctId': 'NCT00285233', 'briefTitle': 'Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'An Open-label Pilot Study of Delayed Mycophenolate Mofetil Instead of Tacrolimus Combined With Anti-thymocyte Globulin, Daclizumab, Etanercept, and Sirolimus in Single-donor, Solitary Islet Allograft Recipients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '0006M55241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: Allogeneic islets of Langerhans transplant']}], 'interventions': [{'name': 'Allogeneic islets of Langerhans transplant', 'type': 'BIOLOGICAL', 'otherNames': ['Islet transplant'], 'description': 'Allogeneic islets of Langerhans transplant', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Bernhard J. Hering, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}