Everolimus and Epoetin for Sustained Liver Transplant Tolerance (EVEREST)(ITN101ST)
National Institute of Allergy and Infectious Diseases (NIAID)
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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\^…
Interventions
- DrugEverolimus
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.
- DrugEpoetin 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 MedicineSan Francisco, California
- Northwestern University Feinberg School of MedicineChicago, Illinois
- University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania