Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05655273 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation Primary completion date: Dec 31, 2023 to Apr 30, 2025 · Start date changed from estimate of Jun 1, 2023 to Jan 1, 2024 · Study sites: 0 to 1 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Dec 31, 2023 to Apr 30, 2025
    • Start date changed from estimate of Jun 1, 2023 to Jan 1, 2024
    • Study sites: 0 to 1
    • Completion date: Oct 31, 2024 to Feb 28, 2026
  3. Start date: Jan 1, 2023 to Jun 1, 2023v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov