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RECRUITING
NCT05089604
PHASE4

Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations

Sponsor: University of British Columbia

View on ClinicalTrials.gov

Summary

This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.

Official title: Tacrolimus Associated Tremors in Liver Transplant Recipients: a Randomized Open Label Trial Comparing De Novo Extended-release Once Daily (LCP-TAC) and Twice Daily Immediate-release (IR-TAC) Tacrolimus Formulations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2023-01-09

Completion Date

2026-12-31

Last Updated

2024-01-02

Healthy Volunteers

No

Interventions

DRUG

Tacrolimus, Immediate Release, Oral

Twice Daily Tacrolimus

DRUG

Tacrolimus Extended Release Oral Tablet

Once Daily Tacrolimus

Locations (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada