Once-daily tacrolimus regimens during the first year after liver transplant
Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation
This will try once-daily tacrolimus with mycophenolate to see if simpler dosing helps people take their medicines and protects the transplanted liver during the first year after a liver transplant.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 18 sites (Besançon and 17 other locations) |
| Trial ID | NCT06354179 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults who received their first liver transplant from a deceased donor within the past four weeks, can give informed consent, and have no contraindications to tacrolimus or mycophenolate.
Not a fit: Patients with split-liver or additional organ transplants, contraindications to tacrolimus or MMF, pregnant or breastfeeding women, or those on interacting HIV/HCV protease inhibitors are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, simpler once-daily regimens could improve medication adherence and reduce late rejection and graft loss after liver transplantation.
How similar studies have performed: Other trials of once-daily tacrolimus formulations have generally shown comparable graft outcomes to twice-daily dosing and some improvements in adherence, so this approach builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Besançon and 17 other locations
- CHU de Besançon - Hôpital Jean Minjoz — Besançon, France (Recruiting)
- Beaujon hospital - APHP — Clichy, France (Recruiting)
- CHU de Dijon Bourgogne — Dijon, France (Recruiting)
- CHu de Grenoble — Grenoble, France (Not_yet_recruiting)
- Lille university hospital — Lille, France (Recruiting)
- Limoges university hospital — Limoges, France (Recruiting)
- Lyon university hospital — Lyon, France (Recruiting)
- Aphp — Marseille, France (Recruiting)
- Montpellier university hospital — Montpellier, France (Recruiting)
- Nice university hospital — Nice, France (Recruiting)
- Pitie Salpetriere hospital - APHP — Paris, France (Recruiting)
- Bordeaux university hospital — Pessac, France (Recruiting)
- Poitiers university hospital — Poitiers, France (Recruiting)
- Rennes university hospital — Rennes, France (Recruiting)
- Strasbourg university hospital — Strasbourg, France (Recruiting)
- Toulouse university hospital — Toulouse, France (Recruiting)
- Tours university Hospital — Tours, France (Recruiting)
- Paul Brousse Hospital - APHP — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Caroline MONCHAUD, Pharm D
- Email: caroline.monchaud@inserm.fr
- Phone: 555056140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.