Trials / Recruiting
RecruitingNCT06183892
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- RenJi Hospital · Academic / Other
- Sex
- All
- Age
- 6 Months – 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2024-03-04
- Primary completion
- 2025-07-01
- Completion
- 2026-07-01
- First posted
- 2023-12-28
- Last updated
- 2024-12-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06183892. Inclusion in this directory is not an endorsement.