Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

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.

NCT Number	NCT06147648
Lead Sponsor	Beijing Tsinghua Chang Gung Hospital
Conditions	Liver Transplantation
Enrollment	352 participants
Start Date	2023-12-01
Primary Completion	2025-07-30 (estimated)
Study Completion	2026-07-30 (estimated)
Updated on ClinicalTrials.gov	2023-11-27