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Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)

RecruitingPhase 4Ages 18 Years - anyAllUniversity Hospital, Limoges
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In plain words

What the trial is, and whether it could suit you

World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppressio

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📋 Eligibility rules (as published)
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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What it tests

  • XR-tacrolimus QD + MMF BID then MMF QD
  • XR-tacrolimus QD + MMF BID
  • LCP-tacrolimus QD + MMF QD then MMF QD
  • LCP-tacrolimus QD + MMF BID
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Where

18 sites
CHU de Besançon - Hôpital Jean Minjoz
Besançon, France
Beaujon hospital - APHP
Clichy, France
CHU de Dijon Bourgogne
Dijon, France
CHu de Grenoble
Grenoble, France
Lille university hospital
Lille, France
Limoges university hospital
Limoges, France
Lyon university hospital
Lyon, France
APHP
Marseille, France

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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