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

NCT06183892 | Recruiting

• 1 other identifier: Renji-LY2023-076-B
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant

Keywords

liver transplant; pediatric liver transplant; tacrolimus

Outcome Measures

Primary Outcomes (2)

• Incidence of biopsy-confirmed acute rejection (BPAR)

  biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification

  12 months

• Incidence of allograft liver fibrosis

  allograft liver fibrosis would be evaluated by LAFSc

  12 months

Secondary Outcomes (5)

• Liver function

  12 months

• Kidney function

  12 months

• Liver allograft survival rate

  12 months

• The rate of drug change

  12 months

• Incidence of infection

  12 months

Study Arms (1)

Prolonged-release tacrolimus

EXPERIMENTAL

Drug: Tacrolimus Sustained-release Capsules

Interventions

Tacrolimus Sustained-release Capsules DRUG

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)

Prolonged-release tacrolimus

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

RECRUITING

Study Officials

• Qiang Xia, Prof. MD

  Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

  STUDY CHAIR

• Hao Feng, MD., Ph.D

  Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Feng, MD., Ph.D

CONTACT

008615000901110; surgeonfeng@live.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: December 28, 2023
• Study Start: March 4, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)