Actively Recruiting
EVR and EPO for Liver Transplant Tolerance
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-06
20
Participants Needed
3
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
EVR and EPO for Liver Transplant Tolerance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- 1 to 10 years post-liver transplant
- On tacrolimus-containing maintenance immunosuppression regimen without corticosteroids
- Mycophenolate mofetil (MMF) dose \u22642000 mg daily or mycophenolic acid (MPA) dose \u22641440 mg daily if using MMF or MPA
- Tacrolimus level less than 8 ng/ml on two most recent lab results within 3 months
- Gamma glutamyl transferase (GGT) and alanine transaminase (ALT) less than or equal to upper limit of normal
- Estimated glomerular filtration rate (GFR) greater than or equal to 40 mL/min/1.73 m2 using CKD-EPI 2021 equation
- Female participants of reproductive potential must have a negative pregnancy test at study entry
- Female participants of reproductive potential must agree to use FDA-approved birth control methods during the study
- Current vaccinations or documented immunity per DAIT vaccine guidance for transplant trials
- Negative recent tuberculosis (TB) test or completed latent TB infection therapy as appropriate
- Negative FDA-approved HIV test within 12 months prior to screening or documented in medical record
- Negative hepatitis C antibody test within 12 months prior to screening or documented history with negative RNA tests if previously treated
- Negative hepatitis B surface antigen and core antibody if no history of hepatitis B; if history present, must be on antiviral therapy with negative HBV DNA PCR at screening
You will not qualify if you...
- Unable to comply with study protocol
- Medical condition requiring chronic systemic corticosteroids (inhaled steroids allowed)
- Autoimmune liver diseases including autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis
- Rejection diagnosis within 52 weeks before screening
- Donor HLA typing unavailable or inadequate for donor-specific antibody assignment
- Need for uninterrupted anticoagulation
- Active or recent invasive fungal or mycobacterial infection within 1 year
- HIV positive
- Serious uncontrolled major organ disease
- Recipient of non-liver solid organ or bone marrow transplant
- Infection requiring hospitalization and IV antibiotics within 4 weeks or oral antibiotics within 2 weeks
- Malignancy within last 5 years except certain treated skin or cervical cancers and specific hepatocellular carcinoma criteria
- Neutropenia (ANC <1000/microliter) within 4 weeks prior to enrollment
- History of hypersensitivity to epoetin or mTOR inhibitors
- History of angioedema
- Certain hereditary disorders affecting carbohydrate metabolism (e.g., galactose intolerance)
- Genetic disorders predisposing to thrombosis
- History of venous or arterial thrombosis, acute myocardial infarction, or thrombotic stroke except isolated portal vein thrombosis
- History of Budd Chiari syndrome
- Hemoglobin greater than 13.5 g/dl
- Plasma fibrinogen or D-dimer levels above normal
- Planned major surgery within 12 months
- Uncontrolled severe hypertension
- Uncontrolled significant cardiac arrhythmia
- Proteinuria with urine protein/creatinine ratio above 0.5 g/g
- Severe hyperlipidemia with total cholesterol above 350 mg/dl or triglycerides above 1000 mg/dl
- Current alcohol, drug, or chemical dependency
- Currently pregnant or nursing
- Current treatment with estrogen-containing oral contraceptives or systemic estrogen replacement
- Treatment with immunomodulatory biological drugs within 12 weeks prior to study entry
- Immunization with live vaccine within 2 weeks of baseline visit
- Treatment with investigational agents within 4 weeks or 5 half-lives prior to screening
- Other medical problems or lab findings posing risks or interfering with study participation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of California San Francisco School of Medicine
San Francisco, California, United States, 94143
Actively Recruiting
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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