Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT05662267
Status:
UNKNOWN
Last Update Posted:
2022-12-22
First Post:
2022-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2022-12-14', 'studyFirstSubmitQcDate': '2022-12-21', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft failure defined by death-uncensored graft survival, i.e. the return to dialysis or death', 'timeFrame': 'From the date of islet transplantation (or time-point equivalent in the control group) until the date of death from any cause or return to dialysis, whichever comes first, assessed up to 240 months.'}], 'secondaryOutcomes': [{'measure': 'Patient survival', 'timeFrame': 'From the date of islet transplantation (or time-point equivalent in the control group) until the date of death from any cause, assessed up to 240 months'}, {'measure': 'Death-censored graft survival', 'timeFrame': 'From the date of islet transplantation (or time-point equivalent in the control group) until the date of death from any cause, assessed up to 240 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Pancreatic Islet Transplantation', 'Kidney Transplantation'], 'conditions': ['type1diabetes', 'Renal Failure', 'End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': "Islet transplantation is associated with a benefit on glycaemic control compared to optimized insulin therapy in recent clinical trials. However, there is a lack of evidence concerning the long-term impact of islet transplantation on type 1 diabetic kidney transplant recipients' prognosis. The objective of the study is to assess the impact of islet transplantation in patients with type 1 diabetes and a kidney transplantation on the risk of graft failure. Every type 1 diabetic recipient transplanted with a kidney in France between 2000 and 2017 is included. Patients transplanted with pancreatic islets are compared to controls treated with insulin alone according to a matching method based on time-dependent propensity scores which allow to ensure patients comparability at the time of islet transplantation. Time-dependent propensity scores are built according to variables associated with both the probabilities of being transplanted with islets and the outcome of interest. These variables are assessed by a direct acyclic graph. The primary outcome consists in death-uncensored graft survival, defined by death or return to dialysis. Secondary outcomes include the risk of death, or the risk of death-censored graft survival."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'French patients with type 1 diabetes, transplanted between 2000 and 2017 with a kidney transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is aged over 18\n* With type 1 diabetes\n* With End-Stage Renal disease\n* Transplanted with a kidney\n* Between 2000 and 2017\n\nExclusion Criteria:\n\n* Patients with type 2 diabetes\n* Patients with a previous pancreatic transplantation with a pancreatic graft functioning at the time of kidney transplantation.'}, 'identificationModule': {'nctId': 'NCT05662267', 'acronym': 'KA-IAK', 'briefTitle': 'Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Targeted Trial Emulation of Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Transplant Recipients : a French Nationwide Cohort Study', 'orgStudyIdInfo': {'id': 'HLJ_2022_03'}, 'secondaryIdInfos': [{'id': 'DEC19-483', 'type': 'OTHER', 'domain': 'Number register data CHU Lille'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Islet-after-kidney group', 'description': 'Patients with type 1 diabetes with a kidney transplant received or not an islet transplantation after kidney transplantation. As soon as they received an islet transplantation, they belong to the "Islet-after-kidney group".'}, {'label': 'Kidney alone group', 'description': 'Patients with type 1 diabetes with a kidney transplant who did not receive an islet transplantation belong to the " Kidney alone group ".', 'interventionNames': ['Other: Pancreatic islet transplantation after kidney transplantation']}], 'interventions': [{'name': 'Pancreatic islet transplantation after kidney transplantation', 'type': 'OTHER', 'description': 'Pancreatic islet transplantation consists in the intrahepatic transplantation of pancreatic islets, as a result of enzymatic digestion of a deceased-donor pancreas.', 'armGroupLabels': ['Kidney alone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hop Claude Huriez Chu Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Medhi Maanaoui, MD,PhD', 'role': 'CONTACT', 'email': 'mehdi.maanaoui@chru-lille.fr', 'phone': '0320445962', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Medhi Maanaoui, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agence de La Biomédecine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}