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Extended-Release Tacrolimus Following Liver Transplantation

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Alberta
NCT05242315 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ca

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📋 Eligibility rules (as published)
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
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What it tests

  • Envarsus Oral Product
  • Prograf (SOC)
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Where

1 site
Univerity of Alberta
Edmonton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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