Could a drug combo free liver transplant patients from daily anti-rejection pills?
NCT ID NCT06832189
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether switching from the standard anti-rejection drug tacrolimus to everolimus plus epoetin can safely allow liver transplant recipients to stop all immunosuppressants. Twenty stable adult patients who received a liver transplant 1–10 years ago will take part. The main goal is to see if this approach is safe and can lead to 'operational tolerance'—where the body accepts the new liver without needing lifelong medication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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\^2 using the CKD-EPI 2021 equation 6. Female subjects of reproductive potential must have a negative pregnancy test upon study entry 7. Female subjects with reproductive potential, must agree to use Food and Drug Administration (FDA)-approved methods of birth control for the duration of the study 8. Subjects must have current vaccinations or documented immunity as per the Division of Allergy, Immunology, and Transplantation (DAIT) vaccine guidance for subjects in transplant trials 9. Negative result of most recent tuberculosis (TB) testing or appropriately completed latent tuberculosis infection (LTBI) therapy. Testing should be conducted using either a purified protein derivative (PPD) or interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB). Results from tests performed within 12 months prior to study entry are acceptable in the absence of any intervening exposure to TB. Subjects with a positive test for LTBI must complete appropriate therapy for LTBI. LTBI treatment regimens should be among those endorsed by the Centers for Disease Control and Prevention (CDC) 10. Negative FDA-approved test for human immunodeficiency virus (HIV) diagnosis at screening or as documented in medical record, up to 12 months prior to screening) 11. Negative hepatitis C antibody test at screening or as documented in medical record, up to 12 months prior to screening, in subjects without a history of hepatitis C. If there is a history of treated hepatitis C, then documentation of two consecutive negative hepatitis C virus (HCV) quantitative RNA polymerase chain reaction (PCR) tests separated by at least 3 months is required. Untreated subjects with positive HCV antibody and a single negative quantitative HCV RNA are eligible. Historical negative HCV RNA results are acceptable in the above two cases with positive HCV antibody 12. Negative hepatitis B surface antigen and negative hepatitis B core antibody in subjects without a history of hepatitis B virus (HBV) infection, up to 12 months prior to screening. Those with known hepatitis B infection or positive hepatitis B surface antigen or positive hepatitis B core antibody must be on antiviral therapy and have negative HBV DNA quantitative PCR at screening Exclusion Criteria: 1. Inability of a subject to comply with study protocol 2. Any medical condition requiring chronic systemic corticosteroid, e.g., severe reactive airways disease. Use of inhaled steroids is not an exclusion 3. Autoimmune cause of liver disease (including autoimmune hepatitis (AIH), primary sclerosing cholangitis, primary biliary cirrhosis) 4. Diagnosis of rejection within 52 weeks prior to screening 5. Donor human leukocyte antigen (HLA) typing unavailable or inadequate for assigning donor-specific antibody (DSA) 6. Need for uninterrupted anticoagulation 7. Known active current or history of invasive fungal infection, or mycobacterial infection within 1 year prior to screening 8. Human immunodeficiency virus (HIV)-positive 9. Serious uncontrolled concomitant major organ disease 10. Recipient of non-liver solid organ or bone marrow transplant 11. Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks 12. Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin or treated in situ cervical cancer. History of hepatocellular carcinoma in the explanted liver is acceptable provided that 1. the last alpha fetoprotein obtained within 3 months prior to liver transplantation was \< 400 microg/L, and 2. the recipients' explanted liver did not have evidence of increased risk of recurrent cancer, i.e., explant was within the Milan criteria, with no vascular invasion, and with no cholangiocarcinoma morphology 13. Neutropenia (absolute neutrophil count or ANC \<1000 microliter) within 4 weeks prior to study enrollment 14. History of hypersensitivity to Epoetin (EPO) or mammalian Target of Rapamycin inhibitor (mTOR-I) 15. History of angioedema 16. History of hereditary disorders of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. History of lactose intolerance is not an exclusion 17. History of genetic disorders predisposing to thrombosis including but not limited to Factor V Leiden mutation, prothrombin 20210, protein C deficiency, protein S deficiency, antithrombin III deficiency 18. History of venous or arterial thrombosis or thromboembolism, acute MI, or thrombotic stroke except for a history of isolated portal vein thrombosis in the setting of hepatic cirrhosis 19. History of Budd Chiari syndrome 20. Hemoglobin \> 13.5 g/dl 21. Plasma fibrinogen or D-dimer level \> ULN 22. Planned major surgery within the next 12 months 23. Uncontrolled severe hypertension 24. Uncontrolled clinically significant cardiac arrhythmia 25. Proteinuria with urine protein/creatinine \>0.5 g/g 26. Severe hyperlipidemia with total cholesterol \>350 mg/dl or triglycerides \>1000 mg/dl 27. Current alcohol, drug, or chemical dependency 28. Currently pregnant or nursing 29. Current treatment with an estrogen-containing oral contraceptive, or systemic estrogen replacement therapy 30. Treatment with an immunomodulatory biological drug within 12 weeks of study entry 31. Immunization with live vaccine within 2 weeks of study baseline visit 32. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening 33. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern University Feinberg School of Medicine
RECRUITINGChicago, Illinois, 60611, United States
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University of California San Francisco School of Medicine
RECRUITINGSan Francisco, California, 94143, United States
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University of Pennsylvania Medical Center
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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