Study of Once-Daily Immunosuppressive Drug Regimens After Liver Transplantation to Improve Treatment and Quality of Life

What this Trial Is About

Researchers are investigating the use of simpler immunosuppressive drug schedules for adults who have received a liver transplant. The study focuses on improving adherence to medication and quality of life by comparing once-daily versus twice-daily dosing of key drugs such as tacrolimus and mycophenolate mofetil. This is important because non-adherence to immunosuppressive treatment is common and can lead to graft failure and other complications. The study is a phase 4 randomized trial sponsored by the University Hospital, Limoges. The trial compares three groups of liver transplant recipients starting treatment six months after transplantation. One group receives once-daily extended-release tacrolimus LCP-tacrolimus with mycophenolate mofetil given once daily after an initial period of twice daily dosing. Another group receives the same tacrolimus with twice-daily mycophenolate, and a third group receives a different tacrolimus formulation XR-tacrolimus with mycophenolate given twice daily, switching to once daily after six months. Dose adjustments are made using blood level monitoring techniques, including microsampling devices for easier home testing. Participants will be followed for one year to measure treatment failure, then observed for an additional six months to assess adherence, quality of life, adverse events, and drug exposure levels. Assessments include blood tests to estimate drug levels, questionnaires, and safety monitoring. This trial aims to determine whether once-daily dosing is not inferior to twice-daily regimens and whether it improves patient adherence and quality of life after liver transplantation.

Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)