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NOT YET RECRUITING
NCT06147648
PHASE4

Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

Sponsor: Beijing Tsinghua Chang Gung Hospital

View on ClinicalTrials.gov

Summary

Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Moreover, there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients. Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period. At the same time, patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery, and the proportion of drug conversion needs to be further explored. This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation. Furthermore, it seeks to investigate the impact of this conversion on indicators such as liver function, kidney function, metabolic disease incidence, and infection incidence in patients.

Official title: Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2023-12-01

Completion Date

2026-07-30

Last Updated

2023-11-27

Healthy Volunteers

No

Interventions

DRUG

Tacrolimus Sustained-release Capsules

Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation