Status:
RECRUITING
Extended-Release Tacrolimus Following Liver Transplantation
Lead Sponsor:
University of Alberta
Conditions:
Liver Transplant; Complications
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sens...
Detailed Description
PURPOSE To assess the impact of Envarsus on toxicity and clinical outcomes in participants following liver transplant. Tacrolimus-based immunosuppression is the standard of care following liver trans...
Eligibility Criteria
Inclusion
- \- Adult individuals transplanted at the University of Alberta
Exclusion
- Individuals with congenital long QT syndrome
- Patients with elevated bilirubin \> 100 umol/L post-LT (at day 3)
- Patients with chronic kidney disease (eGFR \< 45 ml per minute per 1.73 m2)
- Patients with acute kidney injury requiring discontinuation of calcineurin inhibitors.
- Patients who have hepatocellular carcinoma, require a re-transplant, or receive multi-visceral transplant
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2034
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05242315
Start Date
May 15 2022
End Date
February 15 2034
Last Update
August 21 2025
Active Locations (1)
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1
Univerity of Alberta
Edmonton, Alberta, Canada, T6G 2R3