Exploring prolonged-release tacrolimus for children after liver transplant
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
This study is testing if a new long-lasting version of tacrolimus can help children who have had a liver transplant avoid rejection and stay healthy by making it easier for them to take their medicine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06183892 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 18 years or younger who have undergone liver transplantation and have been stable on immediate-release tacrolimus for at least three months.
Not a fit: Patients who have undergone multi-organ transplants or have a history of allergic reactions to tacrolimus may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute rejection and improve long-term liver function in pediatric transplant recipients.
How similar studies have performed: Previous studies in adult populations have shown that sustained-release tacrolimus can improve transplant outcomes, suggesting potential benefits in pediatric cases as well.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.