Actively Recruiting
Feasibility, Efficacy, and Safety of De Novo Extended-Release Tacrolimus Following Liver Transplantation
Led by University of Alberta · Updated on 2025-08-21
94
Participants Needed
1
Research Sites
374 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a new extended-release formulation of tacrolimus called Envarsus in adults who have undergone liver transplantation. The study aims to compare this medication against the standard immediate-release tacrolimus (Prograf) to see if Envarsus reduces side effects such as kidney dysfunction, neurotoxicity, and metabolic syndrome, and to assess its safety and effectiveness on clinical outcomes like hospitalizations and graft survival. Participants will be randomly assigned to receive either Envarsus once daily or Prograf twice daily, along with mycophenolate and basiliximab for immune suppression. The first dose will be given within 90 days after liver transplant, and participants will be followed over an 18-month enrollment period. Both groups will take their medication orally at regular times daily, with careful instructions to swallow tablets whole. The study includes a one-year primary analysis and a long-term follow-up of up to 10 years to monitor outcomes. Throughout the study, participants will undergo regular assessments including blood tests for kidney function, metabolic markers, and liver enzymes. Researchers will also collect data on adverse events, episodes of organ rejection, hospitalizations, and quality of life measures. Imaging such as FibroScan will be performed periodically to assess liver stiffness, and muscle quality will be evaluated. Safety and efficacy will be monitored continuously, with the main outcome measured by adverse events within the first year after starting treatment.
CONDITIONS
Brief 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/min/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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 90 days following liver transplant
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Up to 1 year
Participants take either extended-release tacrolimus (Envarsus) once daily or immediate-release tacrolimus (Prograf) twice daily along with other immunosuppressive medications to prevent organ rejection after liver transplant.
Regular outpatient visits for medication management and monitoring
Duration - Up to 10 years
Participants are monitored long-term for safety, kidney function, metabolic health, neurotoxicity, hospitalizations, and survival outcomes after completing treatment.
Periodic assessments including FibroScan every 1 to 2 years and clinical evaluations
Trial Site Locations
Total: 1 location
1
Univerity of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Actively Recruiting
Research Team
R
Rahima A Bhanji, MD
N
Nadia Shular, RN
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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