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RECRUITING
NCT06832189
PHASE1

EVR and EPO for Liver Transplant Tolerance

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-01-21

Completion Date

2030-06-01

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

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

Locations (3)

University of California San Francisco School of Medicine

San Francisco, California, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States