Status:
RECRUITING
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Lead Sponsor:
RenJi Hospital
Conditions:
Liver Transplant
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
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.
Detailed Description
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, le...
Eligibility Criteria
Inclusion
- Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
- Able to completely swallow capsules;
- Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
- Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
- Undergo a programmed liver biopsy;
Exclusion
- Multi-organ combined transplantation or multiple liver transplantation;
- Adjuvant liver transplantation or use of bioartificial liver therapy;
- ABO incompatible children with liver transplantation;
- Allergic to tacrolimus;
- Participation in any other clinical study within 3 months prior to enrollment;
- Use of tacrolimus sustained release capsules before enrollment;
- Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06183892
Start Date
March 4 2024
End Date
July 1 2026
Last Update
December 18 2024
Active Locations (1)
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1
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China