NCT05242315 Extended-Release Tacrolimus Following Liver Transplantation
| NCT ID | NCT05242315 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Alberta |
| Condition | Liver Transplant; Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2022-05-15 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 94 participants in total. It began in 2022-05-15 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant). The investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05242315 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplant; Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05242315 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05242315 currently recruiting?
Yes, NCT05242315 is actively recruiting participants. Contact the research team at rbhanji@ualberta.ca for enrollment information.
Where is the NCT05242315 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05242315 clinical trial?
NCT05242315 is sponsored by University of Alberta. The trial plans to enroll 94 participants.