Using a new form of Tacrolimus after liver transplantation
Official title: Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation
Run by University of Alberta · NCT05242315 · Data updated 2026-11-12
This study is testing a new version of a medication called Envarsus to see if it can help liver transplant patients avoid side effects while still keeping their immune system in check.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 94 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | basiliximab |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | May 15, 2022 |
| Main results expected | December 15, 2026 |
| Study ends | February 15, 2034 |
| Registry record updated | September 15, 2026 |
| Trial ID | NCT05242315 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adult individuals who have recently undergone liver transplantation at the University of Alberta.
✕Probably not a fit
Patients with severe kidney issues, congenital long QT syndrome, or those requiring re-transplantation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and effectiveness of Envarsus, an extended-release formulation of Tacrolimus, in patients who have undergone liver transplantation. The goal is to determine if this new formulation can reduce side effects commonly associated with Tacrolimus, such as kidney dysfunction and neurotoxicity, while maintaining effective immunosuppression. Participants will be monitored for clinical outcomes, including liver function and hospitalization rates, to assess the overall impact of this medication compared to standard Tacrolimus. The study aims to improve post-transplant care and patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced side effects for liver transplant patients taking immunosuppressants.
How similar studies have gone: Previous studies have shown promise with extended-release formulations of Tacrolimus, suggesting potential benefits in reducing side effects, though this specific approach is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adult individuals transplanted at the University of Alberta Exclusion Criteria: * 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
Where it's running
-
Univerity of Alberta
Edmonton, Alberta, Canada Recruiting
Study contacts
- Study coordinator: Rahima A Bhanji, MD
- Email: rbhanji@ualberta.ca
- Phone: 780-492-2235
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.