Could one pill a day keep the transplant safe?
NCT ID NCT06354179
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether taking immunosuppressant drugs just once daily after a liver transplant is as safe and effective as the standard twice-daily schedule. The goal is to make it easier for patients to stick with their lifelong medication, which could improve their quality of life. About 162 adult liver transplant recipients will be followed for one year to compare rejection rates, adherence, and side effects between the two dosing strategies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tacrolimus and mycophenolate mofetil (immunosuppressants)
- What this could lead to
- If successful, this could simplify lifelong medication schedules for liver transplant patients, making it easier to stick to treatment and potentially improving quality of life.
- What could go wrong
- This is a Phase 4 study with 162 participants, so results may not apply to all patients. Simplifying dosing might not improve adherence or could slightly increase rejection risk.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 162 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 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.
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Conditions
The condition(s) this trial relates to.
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.
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The places running it
18 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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APHP
RECRUITINGMarseille, 13000, France
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Beaujon hospital - APHP
RECRUITINGClichy, 92110, France
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Bordeaux university hospital
RECRUITINGPessac, 33604, France
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CHU de Besançon - Hôpital Jean Minjoz
RECRUITINGBesançon, 25000, France
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CHU de Dijon Bourgogne
RECRUITINGDijon, 21000, France
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CHu de Grenoble
NOT_YET_RECRUITINGGrenoble, 38043, France
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Lille university hospital
RECRUITINGLille, 59000, France
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Limoges university hospital
RECRUITINGLimoges, 87042, France
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Lyon university hospital
RECRUITINGLyon, 69000, France
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Montpellier university hospital
RECRUITINGMontpellier, 34000, France
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Nice university hospital
RECRUITINGNice, 06202, France
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Paul Brousse Hospital - APHP
RECRUITINGVillejuif, 94800, France
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Pitie Salpetriere hospital - APHP
RECRUITINGParis, 75013, France
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Poitiers university hospital
RECRUITINGPoitiers, 86000, France
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Rennes university hospital
RECRUITINGRennes, 35033, France
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Strasbourg university hospital
RECRUITINGStrasbourg, 67000, France
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Toulouse university hospital
RECRUITINGToulouse, 31000, France
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Tours university Hospital
RECRUITINGTours, 37000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Device aims to keep donor livers healthier for transplant
- Can a new drug combo shield young hearts from transplant complications?
- A new Anti-Rejection strategy may spare kidney function after liver transplant
- Can a cell test free liver transplant patients from lifelong drugs?
- Smartphone messages may boost medication adherence after liver transplant
- Can one Mega-Dose of an antifungal beat a deadly infection in AIDS patients?