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

Liver Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06183892
• Other study ID #: Renji-LY2023-076-B
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: December 2023
• Source: RenJi Hospital
• Contact: Hao Feng, MD., Ph.D
• Phone: 008615000901110
• Email: surgeonfeng[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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;

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Drug:
• Tacrolimus Sustained-release Capsules
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)

Locations

Country	Name	City	State
China	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of biopsy-confirmed acute rejection (BPAR)	biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification	12 months
Primary	Incidence of allograft liver fibrosis	allograft liver fibrosis would be evaluated by LAFSc	12 months
Secondary	Liver function	alanine transaminase (ALT) and aspartate transaminase (AST), serum bilirubin, prothrombin time (PT), and albumin within and 12 months after conversion	12 months
Secondary	Kidney function	creatinine (Cr) and BUN within and 12 months after conversion	12 months
Secondary	Liver allograft survival rate	Liver allograft survival rate at 12 months after conversion	12 months
Secondary	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)	12 months
Secondary	Incidence of infection	Incidence of infection (viral, bacterial and fungal) at 12 months after conversion	12 months