Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-04 @ 6:44 PM
Study NCT ID:
NCT06183892
Status:
RECRUITING
Last Update Posted:
2024-12-18
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-12-27', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of biopsy-confirmed acute rejection (BPAR)', 'timeFrame': '12 months', 'description': 'biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification'}, {'measure': 'Incidence of allograft liver fibrosis', 'timeFrame': '12 months', 'description': 'allograft liver fibrosis would be evaluated by LAFSc'}], 'secondaryOutcomes': [{'measure': 'Liver function', 'timeFrame': '12 months', 'description': 'alanine transaminase (ALT) and aspartate transaminase (AST), serum bilirubin, prothrombin time (PT), and albumin within and 12 months after conversion'}, {'measure': 'Kidney function', 'timeFrame': '12 months', 'description': 'creatinine (Cr) and BUN within and 12 months after conversion'}, {'measure': 'Liver allograft survival rate', 'timeFrame': '12 months', 'description': 'Liver allograft survival rate at 12 months after conversion'}, {'measure': 'The rate of drug change', 'timeFrame': '12 months', 'description': 'The rate of drug change caused by ultrasonic diagnosis and abnormal liver function index suspected AR (from tacrolimus sustained release to other CNI drugs)'}, {'measure': 'Incidence of infection', 'timeFrame': '12 months', 'description': 'Incidence of infection (viral, bacterial and fungal) at 12 months after conversion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver transplant; pediatric liver transplant; tacrolimus'], 'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.', 'detailedDescription': 'Tacrolimus is a commonly used immunosuppressant after liver transplantation. However, with increased postoperative time and a decline in postoperative compliance, some children may miss medication, leading to acute rejection. Repeated rejection can cause fibrosis of the transplanted liver, seriously impacting graft function and even postoperative survival, sometimes resulting in the need for a second liver transplant. In adult liver transplant recipients, tacrolimus sustained-release capsules have been shown to significantly improve overall and transplanted liver survival compared to conventional formulations (immediate-release tacrolimus，taken twice daily). Therefore, this study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;\n2. Able to completely swallow capsules;\n3. Have been using immediate-release tacrolimus for at least three months prior to study enrollment;\n4. Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;\n5. Undergo a programmed liver biopsy;\n\nExclusion Criteria:\n\n1. Multi-organ combined transplantation or multiple liver transplantation;\n2. Adjuvant liver transplantation or use of bioartificial liver therapy;\n3. ABO incompatible children with liver transplantation;\n4. Allergic to tacrolimus;\n5. Participation in any other clinical study within 3 months prior to enrollment;\n6. Use of tacrolimus sustained release capsules before enrollment;\n7. Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;'}, 'identificationModule': {'nctId': 'NCT06183892', 'briefTitle': 'Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'Renji-LY2023-076-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prolonged-release tacrolimus', 'interventionNames': ['Drug: Tacrolimus Sustained-release Capsules']}], 'interventions': [{'name': 'Tacrolimus Sustained-release Capsules', 'type': 'DRUG', 'description': 'Immediate-release tacrolimus for at least 3 months after liver transplantation, and then convert to tacrolimus sustained-release capsules at a ratio of 1:1 to 1:1.2; Take the medicine once a day on an empty stomach in the morning.\n\n(The specific medication plan is decided by the clinician according to the actual situation)', 'armGroupLabels': ['Prolonged-release tacrolimus']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Feng', 'role': 'CONTACT', 'email': 'surgeonfeng@live.com', 'phone': '+8615000901110'}], 'facility': 'Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hao Feng, MD., Ph.D', 'role': 'CONTACT', 'email': 'surgeonfeng@live.com', 'phone': '008615000901110'}], 'overallOfficials': [{'name': 'Qiang Xia, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU'}, {'name': 'Hao Feng, MD., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}