NCT06832189

EVR and EPO for Liver Transplant Tolerance

Everolimus and Epoetin for Sustained Liver Transplant Tolerance (EVEREST)(ITN101ST)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DRUG	Everolimus	The starting dose of EVR will be based on the maintenance TAC dose of the subject at study entry: 1. EVR 1 mg PO BID if TAC dose is \<=2 mg BID 2. EVR 2 mg PO BID if TAC dose is 2.5-7 mg BID 3. EVR 3 mg PO BID if TAC dose is \>7 mg BID The dosage will be adjusted as needed to achieve and maintain EVR trough concentration of 5-8 ng/mL.
DRUG	Epoetin alfa	The dose used in this study is 10,000 units SC every 8 weeks (at study weeks 16, 24, 32, 40 and 48) for five doses

Timeline

• Start date: 2026-01-21
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2025-02-18
• Last updated: 2026-04-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study