Clinical Trial

Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients

Enrolling by Invitation Phase 4
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Record status
This record was last updated December 11, 2024 (before its estimated April 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Prograf and Envarsus are two different formulations of Tacrolimus which is used as an immunosuppressant in liver transplant (LT) patients. Prograf is currently used as part of the standard immunosuppression regimen for LT recipients at UHN. This study will compare the use of Prograf and Envarsus and their effects on liver and renal function, trough tacrolimus levels, drug-related adverse effects, and patient adherence. Trial design is a pilot randomized trial. The study aims to recruit 40 patients from UHN's LT program and they will be randomized 1:1 to either stay on their current dose of Prograf or be converted to a once-daily equivalent dose of Envarsus. Both groups of patients will be followed for 48 weeks. This study will compare the change from baseline to week 48 in liver and renal function, tacrolimus-related side effects and patient reported outcomes between the two study groups.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-12-08; most recent amendment 2024-12-10.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-06-17
Trial Details
NCT Number NCT05655273
Lead Sponsor University Health Network, Toronto
Collaborators: Paladin Labs Inc.
Conditions Liver Transplant Rejection, Immune System Suppression
Enrollment 40 participants
Start Date 2024-01-01
Primary Completion 2025-04-30 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-12-11