Actively Recruiting
Extended-Release Tacrolimus Following Liver Transplantation
Led by University of Alberta · Updated on 2025-08-21
94
Participants Needed
1
Research Sites
613 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant). The investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.
CONDITIONS
Official Title
Extended-Release Tacrolimus Following Liver Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult individuals transplanted at the University of Alberta
You will not qualify if you...
- Individuals with congenital long QT syndrome
- Patients with elevated bilirubin > 100 umol/L post-liver transplant (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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Univerity of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
Research Team
R
Rahima A Bhanji, MD
CONTACT
N
Nadia Shular, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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