Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2025-12-28 @ 8:40 AM
Study NCT ID:
NCT01999361
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2013-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
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': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'allosensitization after complete islet graft loss', 'timeFrame': '3 years', 'description': 'Allosensitization after complete islet graft loss after completion of two years of Myfortic® maintenance monotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33481552', 'type': 'DERIVED', 'citation': 'Rios P, Baidal D, Lemos J, Camhi SS, Infante M, Padilla N, Alvarez Gil AM, Fuenmayor V, Ambut J, Qasmi FA, Mantero AM, Cayetano SM, Ruiz P, Ricordi C, Alejandro R. Long-term Persistence of Allosensitization After Islet Allograft Failure. Transplantation. 2021 Nov 1;105(11):2490-2498. doi: 10.1097/TP.0000000000003635.'}], 'seeAlsoLinks': [{'url': 'https://diabetesresearch.org/dri-clinical-trials/', 'label': 'Diabetes Research Institute clinical trials'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.', 'detailedDescription': "After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic® monotherapy for 2 years thereafter. After completion of two years of Myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (PRA) levels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients age 18-70 years of age.\n2. Ability to provide written informed consent.\n3. Mentally stable and able to comply with the procedures of the study protocol.\n4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.\n5. History of at least one islet transplant.\n6. Stimulated C-peptide \\<0.3 ng/ml.\n\nExclusion Criteria:\n\n1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension\n2. For female participants: Positive pregnancy test or presently breast-feeding.\n3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.\n4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.\n5. Known active alcohol or substance abuse.\n6. Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction \\<30%.\n7. History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values \\>1.5 times normal upper limits will exclude a patient.\n8. Evidence of inter-current infection.\n9. Active peptic ulcer disease\n10. History on non-adherence to prescribed regimens including immunosuppression.\n11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT01999361', 'briefTitle': 'Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Myfortic® Monotherapy to Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss', 'orgStudyIdInfo': {'id': '20071058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myfortic treatment', 'description': 'Treatment with Myfortic', 'interventionNames': ['Drug: Myfortic']}], 'interventions': [{'name': 'Myfortic', 'type': 'DRUG', 'otherNames': ['mycophenolic acid'], 'description': 'treatment with myfortic', 'armGroupLabels': ['Myfortic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rodolfo Alejandro, MD', 'role': 'CONTACT', 'email': 'islet@med.miami.edu', 'phone': '305-243-5321'}, {'name': 'Ana M Alvarez, APRN', 'role': 'CONTACT', 'email': 'axa383@med.miami.edu', 'phone': '305 243-3389'}, {'name': 'Rodolfo Alejandro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David A Baidal, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Diabetes Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Rodolfo Alejandro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rodolfo Alejandro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Rodolfo Alejandro', 'investigatorAffiliation': 'University of Miami'}}}}