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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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. (The specific medication plan is decided by the clinician according to the actual situation)
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
RECRUITINGIncidence of biopsy-confirmed acute rejection (BPAR)
biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification
Time frame: 12 months
Incidence of allograft liver fibrosis
allograft liver fibrosis would be evaluated by LAFSc
Time frame: 12 months
Liver function
alanine transaminase (ALT) and aspartate transaminase (AST), serum bilirubin, prothrombin time (PT), and albumin within and 12 months after conversion
Time frame: 12 months
Kidney function
creatinine (Cr) and BUN within and 12 months after conversion
Time frame: 12 months
Liver allograft survival rate
Liver allograft survival rate at 12 months after conversion
Time frame: 12 months
The rate of drug change
The rate of drug change caused by ultrasonic diagnosis and abnormal liver function index suspected AR (from tacrolimus sustained release to other CNI drugs)
Time frame: 12 months
Incidence of infection
Incidence of infection (viral, bacterial and fungal) at 12 months after conversion
Time frame: 12 months
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