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NCT06147648

Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.

Not yet recruiting Phase 4 Last updated 27 November 2023
What this trial tests

Phase 4 trial testing Tacrolimus Sustained-release Capsules in Liver Transplantation in 352 participants. Not yet recruiting.

Timeline
1 December 2023
Primary endpoint
30 July 2025
30 July 2026

Quick facts

Lead sponsorBeijing Tsinghua Chang Gung Hospital
PhasePhase 4
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment352
Start date1 December 2023
Primary completion30 July 2025
Estimated completion30 July 2026

Drugs / interventions tested

Conditions studied

Sponsor

Beijing Tsinghua Chang Gung Hospital

Who can join

18 and older, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Tacrolimus Sustained-release Capsules

Trials testing the same drug.

Other recruiting trials for Liver Transplantation

Currently open trials in the same condition.

Other Beijing Tsinghua Chang Gung Hospital trials

Trials by the same sponsor.

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Data sources for this page

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