Actively Recruiting
Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation
Led by University Hospital, Limoges · Updated on 2026-03-19
162
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of simpler immunosuppressive drug schedules for adults who have received a liver transplant. The study focuses on improving adherence to medication and quality of life by comparing once-daily versus twice-daily dosing of key drugs such as tacrolimus and mycophenolate mofetil. This is important because non-adherence to immunosuppressive treatment is common and can lead to graft failure and other complications. The study is a phase 4 randomized trial sponsored by the University Hospital, Limoges. The trial compares three groups of liver transplant recipients starting treatment six months after transplantation. One group receives once-daily extended-release tacrolimus (LCP-tacrolimus) with mycophenolate mofetil given once daily after an initial period of twice daily dosing. Another group receives the same tacrolimus with twice-daily mycophenolate, and a third group receives a different tacrolimus formulation (XR-tacrolimus) with mycophenolate given twice daily, switching to once daily after six months. Dose adjustments are made using blood level monitoring techniques, including microsampling devices for easier home testing. Participants will be followed for one year to measure treatment failure, then observed for an additional six months to assess adherence, quality of life, adverse events, and drug exposure levels. Assessments include blood tests to estimate drug levels, questionnaires, and safety monitoring. This trial aims to determine whether once-daily dosing is not inferior to twice-daily regimens and whether it improves patient adherence and quality of life after liver transplantation.
CONDITIONS
Brief Title
Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 of ENVARSUS4, ADVAGRAF4 and CELLCEPT4
- Patients in whom everolimus-based calcineurin inhibitors minimization is anticipated
- Patients treated with HIV or HCV protease inhibitors
- Pregnant or lactating women
- Women of childbearing potential without any effective contraceptive method 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive immunosuppressive drugs following assigned dosing schedules for the first year after liver transplantation.
Regular visits as per usual care during treatment
Duration - Up to 6 months after treatment
Participants are monitored for treatment adherence, quality of life, and adverse events up to 18 months after transplantation.
Visits up to month 18 for assessments
Trial Site Locations
Total: 18 locations
1
CHU de Besançon - Hôpital Jean Minjoz
Besançon, France, 25000
Actively Recruiting
2
Beaujon hospital - APHP
Clichy, France, 92110
Actively Recruiting
3
CHU de Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
4
CHu de Grenoble
Grenoble, France, 38043
Not Yet Recruiting
5
Lille university hospital
Lille, France, 59000
Actively Recruiting
6
Limoges university hospital
Limoges, France, 87042
Actively Recruiting
7
Lyon university hospital
Lyon, France, 69000
Actively Recruiting
8
APHP
Marseille, France, 13000
Actively Recruiting
9
Montpellier university hospital
Montpellier, France, 34000
Actively Recruiting
10
Nice university hospital
Nice, France, 06202
Actively Recruiting
11
Pitie Salpetriere hospital - APHP
Paris, France, 75013
Actively Recruiting
12
Bordeaux university hospital
Pessac, France, 33604
Actively Recruiting
13
Poitiers university hospital
Poitiers, France, 86000
Actively Recruiting
14
Rennes university hospital
Rennes, France, 35033
Actively Recruiting
15
Strasbourg university hospital
Strasbourg, France, 67000
Actively Recruiting
16
Toulouse university hospital
Toulouse, France, 31000
Actively Recruiting
17
Tours university Hospital
Tours, France, 37000
Actively Recruiting
18
Paul Brousse Hospital - APHP
Villejuif, France, 94800
Actively Recruiting
Research Team
C
Caroline MONCHAUD, Pharm D
H
Hélène ROUSSEL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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