Extended-Release Tacrolimus Following Liver Transplantation

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.

NCT Number	NCT05242315
Lead Sponsor	University of Alberta
Conditions	Liver Transplant; Complications, Renal Insufficiency, Immunosuppressant Adverse Reaction, Metabolic Syndrome, Cardiovascular Diseases
Enrollment	94 participants
Start Date	2022-05-15
Primary Completion	2026-12-15 (estimated)
Study Completion	2034-02-15 (estimated)
Updated on ClinicalTrials.gov	2025-08-21