Clinical trial NCT06183892: Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Official title: Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant
Keywords: liver transplant; pediatric liver transplant; tacrolimus
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Incidence of biopsy-confirmed acute rejection (BPAR)
timeFrame: 12 months
measure: Incidence of allograft liver fibrosis
timeFrame: 12 months
Secondary outcomes:
measure: Liver function
timeFrame: 12 months
measure: Kidney function
timeFrame: 12 months
measure: Liver allograft survival rate
timeFrame: 12 months
measure: The rate of drug change
timeFrame: 12 months
measure: Incidence of infection
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
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
References: