Everolimus + Epoetin Alfa for Liver Transplant

(EVEREST Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Sandy Feng, MD, PhD

Principal Investigator

University of California, San Francisco

Paolo Cravedi, M.D., Ph.D.

Principal Investigator

Icahn School of Medicine at Mount Sinai: Transplantation

Eligibility Criteria

This trial is for stable adult liver transplant recipients currently on a tacrolimus-based immunosuppression regimen. Specific eligibility details are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I am of childbearing age and have a negative pregnancy test.

I understand the study and can give my consent.

I had a liver transplant between 1 and 10 years ago.

Exclusion Criteria

Treatment with any investigational agent within 4 weeks of screening

I was diagnosed with organ rejection less than a year ago.

Inability of a subject to comply with study protocol

Treatment Details

Interventions

• Epoetin alfa (Hormone Therapy)
• Everolimus (mTOR Inhibitor)

Trial Overview The study involves transitioning patients from tacrolimus to Everolimus (EVR), administering five doses of Epoetin alfa (EPO), and attempting phased withdrawal from EVR to induce operational tolerance in liver transplant recipients.

Participant Groups

Group I: Arm1 Experimental Treatment 2 Interventions

Adult liver transplant recipients on a TAC-based IS regimen will transition from Tacrolimus (TAC) to Everolimus (EV), receive five doses of epoetin alfa epoetin alfa (EPO) and concurrently initiate phased withdrawal from EVR. Target accrual for the study is 20 subjects who receive any dose of EPO, and up to 20 donors.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+