EVR and EPO for Liver Transplant Tolerance

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06832189
Phase
PHASE1
Status
Recruiting
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Conditions

  • Liver Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Everolimus — DRUG
    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.
  • Epoetin alfa — DRUG
    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

Study Details

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

Key Dates

Start date
Jan 21, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2030
Completion
Jun 1, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm1
    Adult liver transplant recipients on a TAC-based IS regimen will transition from Tacrolimus (TAC) to Everolimus (EVR), receive five doses of 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.

Primary Outcome Measure

The proportion of subjects free of opportunistic infection attributed to the investigational study regimen [ Time Frame: At 52 weeks post-immunosuppression withdrawal (ISW) ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California San Francisco School of MedicineSan FranciscoCalifornia94143
Joanne Kwan, BS
[email protected]
415-476-2574
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Laura Adams, RN
[email protected]
312-694-0242
University of Pennsylvania Medical CenterPhiladelphiaPennsylvania19104
Mary Kaminski, PA
[email protected]
215-847-8750

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By research site
University of California San Francisco School of Medicine· San Francisco, CANorthwestern University Feinberg School of Medicine· Chicago, ILUniversity of Pennsylvania Medical Center· Philadelphia, PA

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