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Could a single pill replace a cocktail of Anti-Rejection drugs after liver transplant?

NCT ID NCT06280950

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Baylor Medical Center (Site #: 71153)

    RECRUITING

    Dallas, Texas, 75246, United States

  • Duke University Medical Center (Site #: 71139)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Houston Methodist (Site #: 71120)

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Icahn School of Medicine at Mount Sinai (Site #: 71115)

    RECRUITING

    New York, New York, 10029, United States

  • Mayo Clinic Hospital Arizona (Site #: 71144)

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Northwestern University (Site #: 71110)

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ronald Regan at UCLA Medical Center (Site #: 71123)

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, San Diego (Site #: 71179)

    NOT_YET_RECRUITING

    San Diego, California, 92121, United States

  • University of California, San Francisco (Site #: 71108)

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Michigan (Site #: 71154)

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania (Site #: 71111)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center (Site #: 71170)

    RECRUITING

    Pittsburgh, Pennsylvania, 15260, United States

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