drugset / Trial / NCT06147648

Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

NCT06147648

Phase 4 Not yet recruiting 352 enrolled Beijing Tsinghua Chang Gung Hospital
NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2023-12-01
Primary completion
2025-07-30
Completion
2026-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule

Indications

No indication recorded.