Using a new form of Tacrolimus after liver transplantation
Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation
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 |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | basiliximab |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05242315 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adult individuals who have recently undergone liver transplantation at the University of Alberta.
Not a fit: Patients with severe kidney issues, congenital long QT syndrome, or those requiring re-transplantation will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edmonton, Alberta
- Univerity of Alberta — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Rahima A Bhanji, MD
- Email: rbhanji@ualberta.ca
- Phone: 780-492-2235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.