Everolimus-based calcineurin-free immunosuppression one year after liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, prospective, multicenter, open-label study in adult liver transplant recipients who are 12 to 36 months post-transplant and have stable graft function. Participants on calcineurin inhibitor–based maintenance therapy with low rejection risk are randomized to regimens that further reduce or modify immunosuppression, comparing everolimus-containing, CNI-sparing approaches. Enrollment focuses on those without graft dysfunction, with a surveillance biopsy showing no relevant injury by BANFFmini criteria, and with adequate renal function. Eligible patients must be 18–79 years old, have single-organ liver grafts, and meet specific liver enzyme thresholds; certain intolerance or comorbidity risks exclude participation. The study is led by Hannover Medical School with collaborators in the UK and several German centers, and uses everolimus, tacrolimus, or cyclosporine as study interventions.

Why it matters

Who can join: the full rules

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)

Where it's running

• Medical School Hannover, Department of Gastroenterology, Hepatology, Endocrinology and Infectious Diseases
  Hanover, Lower Saxony, Germany Recruiting
• University Hospital Heidelberg; Department of Internal Medicine IV
  Heidelberg, Baden-Wurttemberg, Germany Not yet recruiting
• University Hospital Tübingen, Department of Internal Medicine I
  Tübingen, Baden-Wurttemberg, Germany Not yet recruiting
• University Hospital Regensburg, Department of Surgery
  Regensburg, Bavaria, Germany Not yet recruiting
• University Hospital Würzburg, Department of General, Visceral, Transplant, Vascular, and Pediatric Surgery
  Würzburg, Bavaria, Germany Not yet recruiting
• University Medical Center Hamburg, I. Department of Medicine, Department of Hepatobiliary and Transplantation Surgery
  Hamburg, Free and Hanseatic City of Hamburg, Germany Not yet recruiting

Study contacts

• Principal investigator: Richard Taubert, Professor — Medical School Hannover
• Study coordinator: Sophia Heinrich, Doctor
• Email: heinrich.sophia@mh-hannover.de
• Phone: +49-511-532

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.