L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), via son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) et son Working Party on Immune and Inflammatory Diseases (IIWP), a \u00e9labor\u00e9 un projet de document d\u2019orientation (\u00ab concept paper \u00bb) sur les essais cliniques chez les receveurs de transplantation r\u00e9nale. Ce document compl\u00e8te la ligne directrice d\u00e9j\u00e0 existante sur l\u2019investigation clinique des immunosuppresseurs pour la transplantation d\u2019organes solides (r\u00e9f\u00e9rence CHMP\/EWP\/263148\/06).<\/p>\n
Le projet a \u00e9t\u00e9 approuv\u00e9 par le groupe de travail IIWP en juin 2026 puis adopt\u00e9 par le CHMP pour mise en consultation le 5 octobre 2026. La consultation publique d\u00e9bute le 16 octobre 2026 et se termine le 31 janvier 2027. Les commentaires doivent \u00eatre transmis via un formulaire EUSurvey d\u00e9di\u00e9, avec un appui technique assur\u00e9 par le support EUSurvey.<\/p>\n
Le champ de la future orientation couvre des th\u00e9matiques sp\u00e9cifiques \u00e0 la transplantation r\u00e9nale dans l\u2019Union europ\u00e9enne, o\u00f9 cette pratique est largement r\u00e9pandue mais avec des variations importantes entre \u00c9tats membres en termes de taux de transplantation et de sources de donneurs. Il est rappel\u00e9 que, pour les patients atteints d\u2019insuffisance r\u00e9nale terminale, les r\u00e9sultats cliniques de la transplantation (survie et qualit\u00e9 de vie) sont nettement sup\u00e9rieurs \u00e0 ceux de la dialyse, m\u00eame si la dur\u00e9e de vie fonctionnelle des greffons r\u00e9naux reste significativement inf\u00e9rieure \u00e0 celle des reins natifs.<\/p>\n
Le document met en avant plusieurs enjeux cliniques majeurs pour les receveurs de greffe r\u00e9nale, qui structurent les besoins en recherche clinique et en \u00e9valuation des m\u00e9dicaments : pr\u00e9vention et prise en charge du rejet de greffe, risques infectieux li\u00e9s \u00e0 l\u2019immunosuppression, complications des traitements immunosuppresseurs, \u00e9chec du greffon et complexit\u00e9 de la prise en charge globale des patients transplant\u00e9s. Parmi les points techniques identifi\u00e9s comme importants pour les futurs essais figurent notamment la survie du greffon, la n\u00e9phrotoxicit\u00e9 des inhibiteurs de la calcineurine, la situation des receveurs sensibilis\u00e9s (anticorps dirig\u00e9s contre le donneur, anticorps r\u00e9actifs contre un panel d\u2019antig\u00e8nes), la fonction retard\u00e9e du greffon, l\u2019induction de tol\u00e9rance, les l\u00e9sions d\u2019isch\u00e9mie-reperfusion et leurs cons\u00e9quences.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont l\u2019EMA, qui coordonne l\u2019\u00e9laboration de ce cadre m\u00e9thodologique, le CHMP, qui adopte et met en consultation le texte, et le groupe de travail IIWP, charg\u00e9 des aspects scientifiques relatifs aux maladies immunes et inflammatoires. Le p\u00e9rim\u00e8tre g\u00e9ographique concern\u00e9 est l\u2019ensemble de l\u2019Union europ\u00e9enne, avec un potentiel int\u00e9r\u00eat comparatif pour les syst\u00e8mes de sant\u00e9 nationaux, compte tenu des diff\u00e9rences de pratiques de transplantation entre pays. Le texte ne comporte pas de donn\u00e9es chiffr\u00e9es d\u00e9taill\u00e9es au-del\u00e0 des r\u00e9f\u00e9rences bibliographiques cit\u00e9es, ni de mesures r\u00e9glementaires imm\u00e9diates, mais vise \u00e0 pr\u00e9parer une future ligne directrice plus op\u00e9rationnelle sur la conduite des essais cliniques chez les patients transplant\u00e9s r\u00e9naux. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" L\u2019Agence europ\u00e9enne des m\u00e9dicaments (EMA), via son Comit\u00e9 des m\u00e9dicaments \u00e0 usage humain (CHMP) et son Working Party on Immune and Inflammatory Diseases (IIWP), a \u00e9labor\u00e9 un projet de document […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-21242","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21242","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21242"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21242\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21242"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21242"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21242"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}