Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients

Not Applicable

Recruiting

• Conditions: Liver Transplant
• Interventions: Drug: Tacrolimus Sustained-release Capsules

• Registration Number: NCT06183892
• Lead Sponsor: RenJi Hospital

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, 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.

Study Timeline

• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-12-27
• Study First Posted: 2023-12-28
• Study Start: 2024-03-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
2. Able to completely swallow capsules;
3. Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
4. Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
5. Undergo a programmed liver biopsy;

Exclusion Criteria

1. Multi-organ combined transplantation or multiple liver transplantation;
2. Adjuvant liver transplantation or use of bioartificial liver therapy;
3. ABO incompatible children with liver transplantation;
4. Allergic to tacrolimus;
5. Participation in any other clinical study within 3 months prior to enrollment;
6. Use of tacrolimus sustained release capsules before enrollment;
7. Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prolonged-release tacrolimus	Tacrolimus Sustained-release Capsules	-

Primary Outcome Measures

Name	Time	Method
Incidence of allograft liver fibrosis	12 months	allograft liver fibrosis would be evaluated by LAFSc
Incidence of biopsy-confirmed acute rejection (BPAR)	12 months	biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification

Secondary Outcome Measures

Name	Time	Method
Kidney function	12 months	creatinine (Cr) and BUN within and 12 months after conversion
Incidence of infection	12 months	Incidence of infection (viral, bacterial and fungal) at 12 months after conversion
Liver allograft survival rate	12 months	Liver allograft survival rate at 12 months after conversion
Liver function	12 months	alanine transaminase (ALT) and aspartate transaminase (AST), serum bilirubin, prothrombin time (PT), and albumin within and 12 months after conversion
The rate of drug change	12 months	The rate of drug change caused by ultrasonic diagnosis and abnormal liver function index suspected AR (from tacrolimus sustained release to other CNI drugs)

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China