Study of Everolimus and Tacrolimus Reduction to Protect Kidney Function in Adult Liver Transplant Patients

What this Trial Is About

This research aims to evaluate the safety, effectiveness, and tolerability of reducing and eventually stopping the anti-rejection medicine tacrolimus in people who have received a liver transplant. The study focuses on maintaining kidney function by using everolimus alone after reducing tacrolimus. It is a phase II nonblinded trial involving liver transplant recipients, with 270 participants randomized between 2 and 3 months after transplant, and an additional observational group of 70 participants. Participants will first add everolimus to their treatment, stopping mycophenolate compounds within 7 days and tapering off prednisone by 6 months after transplant. After tolerating everolimus, they will be randomized into one of two groups one will gradually reduce tacrolimus to everolimus monotherapy, while the other will continue a reduced dose of tacrolimus with everolimus. Those who cannot tolerate everolimus before randomization will join the observational group, stopping everolimus and resuming their prior immunosuppression medications. Throughout the 18 to 20 months of study participation, participants will have regular visits to monitor kidney function, liver graft health, and any adverse events. Assessments include measuring estimated glomerular filtration rate eGFR, liver enzymes, acute rejection episodes, infections, and other complications. Researchers will track changes from enrollment through up to 20 months post-transplant to understand treatment effects and safety.

Expanding Liver Transplant Immunosuppression Minimization Via Everolimus