Safety and Effectiveness of Extended-Release Tacrolimus Envarsus Compared to Immediate-Release Tacrolimus After Liver Transplant

What this Trial Is About

Researchers are evaluating the use of a new extended-release formulation of tacrolimus called Envarsus in adults who have undergone liver transplantation. The study aims to compare this medication against the standard immediate-release tacrolimus Prograf to see if Envarsus reduces side effects such as kidney dysfunction, neurotoxicity, and metabolic syndrome, and to assess its safety and effectiveness on clinical outcomes like hospitalizations and graft survival. Participants will be randomly assigned to receive either Envarsus once daily or Prograf twice daily, along with mycophenolate and basiliximab for immune suppression. The first dose will be given within 90 days after liver transplant, and participants will be followed over an 18-month enrollment period. Both groups will take their medication orally at regular times daily, with careful instructions to swallow tablets whole. The study includes a one-year primary analysis and a long-term follow-up of up to 10 years to monitor outcomes. Throughout the study, participants will undergo regular assessments including blood tests for kidney function, metabolic markers, and liver enzymes. Researchers will also collect data on adverse events, episodes of organ rejection, hospitalizations, and quality of life measures. Imaging such as FibroScan will be performed periodically to assess liver stiffness, and muscle quality will be evaluated. Safety and efficacy will be monitored continuously, with the main outcome measured by adverse events within the first year after starting treatment.

Extended-Release Tacrolimus Following Liver Transplantation