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A new Anti-Rejection strategy may spare kidney function after liver transplant

NCT ID NCT07739914

Disease control Sponsor: Hannover Medical School Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This phase III trial is testing whether switching liver transplant recipients to an everolimus-based, calcineurin inhibitor-free regimen one year after surgery can better preserve kidney function compared to staying on a low-dose calcineurin inhibitor. The study enrolls 150 adults who received a liver transplant 12 to 36 months ago and are at low risk of rejection. Participants are randomly assigned to either the everolimus regimen or the standard low-dose calcineurin inhibitor regimen, and their kidney function is measured over 14 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
everolimus (an mTOR inhibitor) combined with mycophenolate mofetil, compared to low-dose tacrolimus or cyclosporine with or without low-dose mycophenolate mofetil
What this could lead to
If successful, this approach could help liver transplant recipients keep their new organ while reducing the long-term kidney damage caused by standard anti-rejection drugs.
What could go wrong
The trial is relatively small and only includes patients with a low risk of rejection, so results may not apply to everyone. There is also a risk that the drug switch could increase the chance of liver rejection.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

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. Men\*\*, women\*, inter/diverse aged ≥ 18 or \<80 years 2. Signed written informed consent from subject 3. Liver allograft recipients, either deceased or living donor liver transplant 4. Liver transplantation more than 12 months ago and less than 36 months ago 5. Recipients of single organ transplant only 6. LTR on CNI-based maintenance IS 7. Liver enzymes: ALT \< 2x ULN and ALP\< 2 ULN 8. \*Women without childbearing potential defined as follows: * at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or * hysterectomy or uterine agenesis or * ≥ 50 years and in postmenopausal state \> 1 year or * \< 50 years and in postmenopausal state \> 1 year with serum FSH \> 40 IU/l and serum estrogen \< 30 ng/l or a negative estrogen test, both at screening or \*Women of childbearing potential: * who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or * who have sexual relationships with female partners only and/or with sterile male partners or * who are sexually active with fertile male partner, have two negative pregnancy tests with a sensitivity of at least 25 mIU/ml during screening (it is recommended that the second test be performed 8-10 days after the first test) and agree to use at least one highly \*\*\* from the time of screening until 8 weeks after completion of treatment (or even 90 days for males if MMF has been taken previously). Preferably, two complementary forms of contraception should be used simultaneously. Pregnancy tests should be repeated if clinically indicated (e.g. after a contraceptive failure has been reported). Exclusion Criteria: 1. Previous CNI-free IS 2. Acute or chronic rejection within the 36 months prior to screening 3. Prednisolone intake due to another autoimmune disease for more than 8 weeks 4. eGFR \<30ml/min and/or proteinuria \>0.5g/l (to mitigate the risk of worsening renal failure should rejection occur and high level of CNI might be required and proteinuria as a contraindication for mTORI-based therapy) 5. Need for chronic anti-coagulation that cannot be safely discontinued to perform a liver biopsy 6. Inability to participate in frequent monitoring of liver function (every 8 weeks) and clinical visits during the trial duration (38 months) 7. Malignancy or active infection including active, replicative viral hepatitis (chronic hepatitis does not belong to exclusion criteria) 8. Recurrence of underlying liver disease 9. Subjects who are pregnant or breastfeeding 10. Hypersensitivity or intolerance to any of the components of the medications used 11. Participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior enrolment or within five half-lives of the Investigational Medicinal Product (IMP), whichever is longer) 12. Any medical condition which could compromise participation in the study according to the investigator's assessment. 13. Accommodation in an institution pursuant to a court or administrative order 14. Histological exclusion criteria in the baseline screening biopsy: 1. more than mild portal tract inflammation, presence of interface hepatitis, more than mild lobular inflammation 2. presence of biliary inflammation, endothelialitis, portal microvasculitis, central perivenulitis 3. advanced fibrosis (≥2 in any scale of LAF score) 4. evidence of acute or chronic rejection (T cell-mediated or antibody-mediated, plasma-cell-rich, chronic ductopenic rejection)

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Conditions

The condition(s) this trial relates to.

hereditary sensory and autonomic neuropathy liver disorder Rejection, Psychology

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Liver allograft Liver diseases Liver transplantation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 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

  • Charité - University Hospital Berlin; Department of Surgery

    Berlin, State of Berlin, 13353, Germany

  • Medical School Hannover, Department of Gastroenterology, Hepatology, Endocrinology and Infectious Diseases

    Hanover, Lower Saxony, 30625, Germany

  • Otto von Guericke University Magdeburg, Department of Visceral, Vascular, and Transplant Medicine

    Magdeburg, Saxony-Anhalt, 39120, Germany

  • RWTH Aachen University Hospital, Clinic for Gastroenterology, Metabolic Disorders, and Internal Intensive Medicine (Medical Clinic III)

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Schleswig-Holstein University Hospital (UKSH), Department of General, Visceral, Thoracic, Transplant, and Pediatric Surgery, Campus Kiel

    Kiel, Schleswig-Holstein, 24105, Germany

  • University Hospital Bonn, Department of General, Visceral, Transplant, and Vascular Surgery

    Bonn, North Rhine-Westphalia, 53105, Germany

  • University Hospital Essen, Department of Gastroenterology, Hepatology, and Transplant Medicine

    Essen, North Rhine-Westphalia, 45147, Germany

  • University Hospital Heidelberg; Department of Internal Medicine IV

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • University Hospital Jena, Department of General, Visceral, and Vascular Surgery

    Jena, Thuringia, 07747, Germany

  • University Hospital Münster, Department of Internal Medicine B Gastroenterology, Hepatology, Endocrinology, Clinical Infectious Diseases

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Hospital Regensburg, Department of Surgery

    Regensburg, Bavaria, 93053, Germany

  • University Hospital Tübingen, Department of Internal Medicine I

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University Hospital Würzburg, Department of General, Visceral, Transplant, Vascular, and Pediatric Surgery

    Würzburg, Bavaria, 97080, Germany

  • University Medical Center Hamburg, I. Department of Medicine, Department of Hepatobiliary and Transplantation Surgery

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • University Medical Center Rostock, Interdisciplinary Transplant Center, Department of General, Visceral, Thoracic, Vascular, and Transplant Surgery

    Rostock, Mecklenburg-Vorpommern, 18057, Germany

  • University Medical Center of Johannes Gutenberg University Mainz, Department of Internal Medicine I

    Mainz, Rhineland-Palatinate, 55131, Germany

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