Tacrolimus Associated Tremors in Liver Transplant Recipients: A Randomized Open Label Trial Comparing Once Daily Extended-Release (LCPT) and Twice Daily Immediate-Release Tacrolimus

What this Trial Is About

Researchers are evaluating the risk of tremors caused by tacrolimus in adult patients who have received a first-time liver transplant. The study compares two forms of tacrolimus: a once daily extended-release tablet called Envarsus (LCPT) and a twice daily immediate-release form (IR-TAC). Both forms are approved for preventing organ rejection, and the trial aims to see if the extended-release version reduces tremor frequency and severity when used with mycophenolate and short-term steroids. Participants will be randomly assigned to receive either the once daily extended-release tacrolimus or the twice daily immediate-release tacrolimus, alongside standard doses of mycophenolate and short-term corticosteroids. This is an open-label study, meaning patients and researchers know which treatment is given. The study will monitor tremors closely for the first 8 weeks after transplantation using wearable sensors to measure tremor severity objectively. During the study, participants will undergo assessments of tremor incidence and severity, medication adherence, and quality of life related to tremors using specific questionnaires. The primary outcome is the proportion of patients experiencing tacrolimus-induced tremors or stopping tacrolimus due to neurotoxicity at 8 weeks. Secondary outcomes include rates of death, graft loss, or rejection at 12 months and medication adherence at 8 weeks and 12 months. The total study duration involves follow-up for at least one year post-transplant.

Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations