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New treatment option for Liver Transplant; Complications
Official title Extended-Release Tacrolimus Following Liver Transplantation
ClinicalTrials.gov ID: NCT05242315
What this study is testing
What is Envarsus Oral Product?
Envarsus Oral Product is an investigational medicine, given as an once-daily, being studied as a potential treatment for liver transplant; complications.
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
- 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.
- 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's taking place
- 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 - 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?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.