Once-daily tacrolimus regimens during the first 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

Adults who recently received a first liver transplant are assigned to different immunosuppressive schedules using once-daily formulations of tacrolimus (extended-release or LCP) combined with once- or twice-daily mycophenolate. The trial compares several combinations and planned transitions of dosing over the first post-transplant year. Investigators will track medication adherence, graft function, rejection events, and safety outcomes. The aim is to determine whether simplifying dosing improves adherence without increasing rejection or adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Recipients of a first liver allograft from a deceased donor
* Transplanted for less than four weeks at enrolment.
* Without inter-current progressive life-threatening or graft-threatening disease.
* Having signed a written informed consent for their participation in the study.
* Affiliated to, or beneficiary of, a social security regimen

Exclusion Criteria:

* Recipients of a split-liver transplantation.
* Recipients of any transplanted organ other than the liver
* Patient who has undergone colon resection
* Patients under legal protection (guardianship, curatorship).
* Patient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®.
* Patients in whom everolimus-based calcineurin inhibitors (CNI) minimization is anticipated
* Patients treated with HIV or HCV protease inhibitors.
* Pregnant or lactating women.
* Women of childbearing potential without any effective contraceptive method (according to the guidelines of CTFG, Clinical Trial Facilitation Group, related to contraception and pregnancy test in clinical trials) or not practicing sexual abstinence.
* Sexually active men having a female partner, without any effective contraception.
* Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.
* Patients enrolled in another clinical study evaluating drugs or therapeutic strategies potentially interfering with the objectives of the EASY study.

Where it's running

• CHU de Besançon - Hôpital Jean Minjoz
  Besançon, France Recruiting
• Beaujon hospital - APHP
  Clichy, France Recruiting
• CHU de Dijon Bourgogne
  Dijon, France Recruiting
• Lille university hospital
  Lille, France Recruiting
• Limoges university hospital
  Limoges, France Recruiting
• Lyon university hospital
  Lyon, France Recruiting

Study contacts

• Study coordinator: Caroline MONCHAUD, Pharm D
• Email: caroline.monchaud@inserm.fr
• Phone: 555056140

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing two formulations of tacrolimus for liver transplant patients

  This study is testing whether a new extended-release version of tacrolimus causes fewer and less severe tremors in liver transplant patients compared to the standard immediate-release version.

  Recruiting Phase 4 University of British Columbia · Vancouver, British Columbia · NCT05089604

• Thymalfasin added to standard care for adults with sepsis and immune dysfunction

  This study tests whether thymosin alpha-1 helps restore immune function in adults with sepsis who have weakened immunity.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07866118

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

  This trial tests whether switching to or using everolimus with reduced calcineurin inhibitors after year one post-liver transplant can protect kidney function while maintaining graft health in adults at low rejection risk.

  Recruiting Phase 3 Hannover Medical School · Heidelberg, Baden-Wurttemberg and 15 other locations · NCT07739914

• Metabolic and Functional Study of γδ T Cells in Critically Ill Patients

  Researchers will look at how γδ T cells behave in severely ill patients, including those with sepsis, to see how their metabolism and function change.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Outside of the US · NCT07680816

• Sleep quality and its determinants during the liver transplant pathway

  This study tests how sleep quality changes from before liver transplantation to six months after, in adults on the transplant waitlist at a single hospital.

  Recruiting Hospices Civils de Lyon · Lyon · NCT07674355

• Preoperative CIMT and Intraoperative Hemodynamics in Liver Transplant

  This study looks at whether a higher carotid IMT measured before surgery is linked to more unstable blood pressure during liver transplant.

  Recruiting Dicle University · Diyarbakır · NCT07660679

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.