RECRUITINGPhase 4INTERVENTIONAL

Extended-Release Tacrolimus Following Liver Transplantation

Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: \- Adult individuals transplanted at the University of Alberta Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Envarsus Oral Product

as described in arm/group description

DRUG

Prograf (SOC)

Locations (1)

Univerity of Alberta

Edmonton, Alberta, Canada