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Recruiting NCT06183892

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

No phase Interventional Liver Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tacrolimus Sustained-release Capsules.
Who it may be relevant to
Registry conditions: Liver Transplant. Basic parameters: 6 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Incidence of biopsy-confirmed acute rejection (BPAR) [Time frame: 12 months]
  • Incidence of allograft liver fibrosis [Time frame: 12 months]
Secondary outcome measures (5)
  • Liver function [Time frame: 12 months]
  • Kidney function [Time frame: 12 months]
  • Liver allograft survival rate [Time frame: 12 months]
  • The rate of drug change [Time frame: 12 months]
  • Incidence of infection [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT06183892 · Renji-LY2023-076-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗