Phase 1b Study of Everolimus and Epoetin Alfa to Promote Liver Transplant Tolerance in Stable Adults

What this Trial Is About

Researchers are evaluating the safety of using Everolimus EVR and epoetin alfa EPO to induce operational tolerance in stable adult liver transplant recipients who are currently on tacrolimus TAC-based immunosuppression. This open-label, single-arm, multicenter phase 1b study focuses on adults 1 to 10 years after liver transplant. The goal is to assess if switching from TAC to EVR combined with EPO can safely allow phased withdrawal from immunosuppression. Participants will transition from TAC to EVR with dosing adjusted based on their prior TAC dose to maintain specific blood levels of EVR. They will receive five doses of EPO injected under the skin every eight weeks at weeks 16, 24, 32, 40, and 48. As EVR is started, participants will begin a gradual withdrawal from EVR itself under careful monitoring. Up to 20 participants will be enrolled in this study. During the study, researchers will monitor participants for infections, malignancies, serious adverse events, and signs of rejection over a period extending up to 156 weeks after immunosuppression withdrawal. They will assess kidney function, antibody development, graft loss, and overall clinical stability off immunosuppression. Safety and effectiveness of the treatment regimen will be closely followed through laboratory tests, clinical assessments, and medication adjustments throughout the trial period.

EVR and EPO for Liver Transplant Tolerance