Exploring prolonged-release tacrolimus for children after liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of sustained-release tacrolimus capsules on preventing acute rejection and fibrosis in pediatric liver transplant recipients. Tacrolimus is a vital immunosuppressant, but adherence can decline over time, leading to serious complications. By switching to a sustained-release formulation, the study aims to improve medication compliance and overall graft survival. Participants will be monitored for biopsy-proven acute rejection and liver health over the course of the study.

Why it matters

Who can join: the full rules

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;

Where it's running

• Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Hao Feng, MD., Ph.D — Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
• Study coordinator: Hao Feng, MD., Ph.D
• Email: surgeonfeng@live.com
• Phone: 008615000901110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.