Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-27 @ 7:46 PM
Study NCT ID:
NCT05277792
Status:
UNKNOWN
Last Update Posted:
2023-07-28
First Post:
2022-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-06-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.', 'timeFrame': 'Day 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tacrolimus, metabolites, liver transplantation'], 'conditions': ['Blood Concentration of Tacrolimus Metabolites']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.', 'detailedDescription': 'The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity.\n\nA blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Liver transplant patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\> 18 years) of both sexes,\n* Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,\n* Not having expressed their opposition to participation in the study\n\nExclusion Criteria:\n\n* Associated transplantation of another organ\n* Contraindications to TAC administration\n* Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.'}, 'identificationModule': {'nctId': 'NCT05277792', 'acronym': 'STABILE 2', 'briefTitle': 'Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients', 'orgStudyIdInfo': {'id': '35RC20_8890_STABILE 2'}}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel RAYAR, MD-PhD', 'role': 'CONTACT', 'email': 'michel.rayar@chu-rennes.fr', 'phone': '299288498', 'phoneExt': '+33'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Michel RAYAR, MD-PhD', 'role': 'CONTACT', 'email': 'michel.rayar@chu-rennes.fr', 'phone': '299288498', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}