Liver Transplant; Complications study: Envarsus Oral Product vs Prograf
Official title Extended-Release Tacrolimus Following Liver Transplantation
ClinicalTrials.gov ID: NCT05242315
What this study is testing
What is Envarsus Oral Product?
An investigational oral medication being studied to see if it reduces side effects and improves outcomes after liver transplant.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will compare the safety and effectiveness of Envarsus with other tacrolimus formulations, looking at side effects and liver health after transplant.
- Who it's for
- Adults who have had a liver transplant and are taking tacrolimus.
- What's involved
- Participants will take Envarsus and attend regular clinic visits for blood tests, liver function checks, and monitoring of side effects.
- Time commitment
- The study lasts about 12 months, with visits every few weeks to a few months for monitoring and testing.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Adult individuals transplanted at the University of Alberta
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Edmonton, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.