Could a single pill replace a cocktail of Anti-Rejection drugs after liver transplant?
NCT ID NCT06280950
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 5 times
Summary
This study tests whether liver transplant patients can safely switch from a standard anti-rejection drug (tacrolimus) to a different drug (everolimus) to protect their kidneys. About 340 adults who received their first liver transplant will be followed for 18-20 months. The goal is to see if this change keeps the liver healthy while reducing kidney damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- everolimus
- What this could lead to
- If successful, this could allow liver transplant patients to take fewer anti-rejection drugs, reducing kidney damage and simplifying their medication routine.
- What could go wrong
- This is an early phase 2 trial with 340 participants, so results may not apply to everyone. There is a risk of organ rejection or side effects from changing medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- 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 and/or legal guardian must be able to understand and provide informed consent 2. Adult (age greater than or equal to 18 years of age at time of informed consent) recipient of first liver transplant alone (de novo) 3. Estimated glomerular filtration rate \>=30 ml/min/1.73m\^2 at enrollment using the CKD-EPI 2021 equation 4. Treatment with tacrolimus therapy, with or without mycophenolic acid derivatives and/or corticosteroids 5. Female subjects of childbearing potential with negative pregnancy test upon study entry 6. All subjects of reproductive potential agreeing to use contraception for the duration of the study 7. Previous vaccination or documented immunity to varicella, measles, hepatitis B, pneumococcus, influenza, zoster (if \>=19 years old), and 2019-nCoV (COVID-19) as outlined in the DAIT Vaccination Guideline Exclusion Criteria: 1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol 2. Active unresolved systemic viral, bacterial, fungal, or parasitic infection requiring oral or intravenous anti-infective therapy 3. History of autoimmune liver disease including autoimmune hepatitis, primary sclerosing cholangitis, and/or primary biliary cirrhosis, or other contraindications to drug withdrawal 4. History of non-hepatic autoimmune disease requiring current or future systemic immunosuppressive therapy other than per study protocol 5. History post-transplant of Hepatic Artery Thrombosis or Portal Vein Thrombosis. 6. History of recurrent cirrhosis after liver transplantation. 7. Chronic use of systemic glucocorticoids, biological immunomodulatory therapy, or other immunosuppressive agents other than per study protocol 8. History of hepatitis B or C virus infection with detectable viral PCR at enrollment 9. History of prior organ transplantation (liver or other type) 10. History of \>= 2 biopsy-proven acute cellular rejection episodes of any severity, \>=1 moderate to severe rejection episode (histologically defined or requiring lymphodepletion therapy), or \>= 1 antibody- mediated rejection episode 11. Active treatment with any mTOR-inhibitor agent (everolimus, sirolimus) 12. Contraindication to treatment with everolimus (open wound or wound infection; urine protein: creatinine ratio \> 0.5 mg/mg; significant pancytopenia (any of the following: WBC \<1.5 K/uL or ANC \<1000 cells/uL or actively being treated with GCSF; Hb \<8.0; platelet count \<50K); serum triglycerides \> 1000 mg/dL; other per PI) 13. Abnormal liver function tests on study entry: Total Bilirubin (TB)\>1.5 mg/dL and Direct Bilirubin (DB) \>1.0 mg/dL, Alkaline Phosphatase (AP) \>200 U/L, and Alanine Aminotransaminase (ALT)\>60 U/L 14. Pregnant on enrollment or plan to become pregnant during the study period 15. Participation in another clinical trial that would interfere with this study's procedures and intervention: 1. Use of investigational biologic or drug (within 8 weeks of study enrollment) 2. Additional blood collection that would exceed research blood draw limits 3. Any other procedure or intervention, in the investigator's opinion would interfere with this study 16. Received live attenuated vaccine(s) within 2 months of enrollment 17. Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study 18. 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 participant'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
12 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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Baylor Medical Center (Site #: 71153)
RECRUITINGDallas, Texas, 75246, United States
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Duke University Medical Center (Site #: 71139)
RECRUITINGDurham, North Carolina, 27710, United States
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Houston Methodist (Site #: 71120)
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Icahn School of Medicine at Mount Sinai (Site #: 71115)
RECRUITINGNew York, New York, 10029, United States
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Mayo Clinic Hospital Arizona (Site #: 71144)
RECRUITINGPhoenix, Arizona, 85054, United States
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Northwestern University (Site #: 71110)
RECRUITINGChicago, Illinois, 60611, United States
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Ronald Regan at UCLA Medical Center (Site #: 71123)
NOT_YET_RECRUITINGLos Angeles, California, 90095, United States
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University of California, San Diego (Site #: 71179)
NOT_YET_RECRUITINGSan Diego, California, 92121, United States
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University of California, San Francisco (Site #: 71108)
RECRUITINGSan Francisco, California, 94143, United States
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University of Michigan (Site #: 71154)
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Pennsylvania (Site #: 71111)
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Pittsburgh Medical Center (Site #: 71170)
RECRUITINGPittsburgh, Pennsylvania, 15260, United States
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