← Back to Clinical Trials
Recruiting Phase 1 NCT06832189

EVR and EPO for Liver Transplant Tolerance

Trial Parameters

Condition Liver Transplant
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-21
Completion 2030-06-01
Interventions
EverolimusEpoetin alfa

Brief Summary

This is an open label, single-arm, multicenter phase 1b study of stable adult liver transplant recipients on a tacrolimus (TAC)-based immunosuppression (IS) regimen who will transition from TAC to Everolimus (EVR), receive five doses of EPO and concurrently initiate phased withdrawal from EVR. The primary objective is to test the safety of administering Everolimus (EVR) and epoetin alfa (EPO) to induce operational tolerance in stable adult liver transplant recipients

Eligibility Criteria

Inclusion Criteria: 1. Subject must be able to understand and provide informed consent 2. 1-10 years post-liver transplant 3. Tacrolimus-containing maintenance immunosuppression (IS) regimen without corticosteroid. Mycophenolate mofetil (MMF) dose must be \<=2000 mg daily or mycophenolic acid (MPA) dose\<=1440 mg daily (if on MMF or MPA). Tacrolimus level must be \<8 ng/ml on the 2 most recent laboratory results within 3 months. 4. Gamma glutamyl transferase (GGT) and alanine transaminase (ALT) \<= upper limit of normal (ULN) 5. Estimated glomerular filtration rate (GFR) \>=40 mL/min/1.73 m\^2 using the CKD-EPI 2021 equation 6. Female subjects of reproductive potential must have a negative pregnancy test upon study entry 7. Female subjects with reproductive potential, must agree to use Food and Drug Administration (FDA)-approved methods of birth control for the duration of the study 8. Subjects must have current vaccinations or documented immunity as per the Division of Allergy, Immuno

Related Trials