{"doc_desc":{"title":"Etude longitudinale sur des patients ayant subi une greffe r\u00e9nale : pharmaco-\u00e9conomie","idno":"FRESH-PEF5209-fr","producers":[{"name":"Pierre MARQUET","affiliation":"UNIVERSITE DE LIMOGES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5209-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"5209"},{"agency":"FReSH","code":"FRESH-PEF5209"}]},"title":"Etude longitudinale sur des patients ayant subi une greffe r\u00e9nale : pharmaco-\u00e9conomie","alternate_title":"EPHEGREN"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Marie;ESSIG","firstname":"Marie","lastname":"ESSIG","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id"},{"title":"SIREN","uri":"267500452","role":"organisation id"}],"email":"marie.essig@inserm.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","PILabo":"","isContact":true},{"name":"Pierre;MARQUET","firstname":"Pierre","lastname":"MARQUET","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02cp04407","role":"organisation id"},{"title":"SIREN","uri":"198706699","role":"organisation id"}],"email":"pierre.marquet@unilim.fr","affiliationName":"UNIVERSITE DE LIMOGES","PILabo":"","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER ET UNIVERSITAIRE DE LIMOGES (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01tc2d264","role":"sponsor id"},{"title":"SIREN","uri":"268708518","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CENTRE HOSPITALIER ET UNIVERSITAIRE DE LIMOGES (CHU)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01tc2d264"},{"title":"SIREN","uri":"268708518"}]},{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Marie;ESSIG","lastname":"ESSIG","firstname":"Marie","type":"contact","email":"marie.essig@inserm.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/00pg5jh14","role":"organisation id","title":"ROR"},{"uri":"267500452","role":"organisation id","title":"SIREN"}]},{"name":"Pierre;MARQUET","lastname":"MARQUET","firstname":"Pierre","type":"contact","email":"pierre.marquet@unilim.fr","affiliationName":"UNIVERSITE DE LIMOGES","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02cp04407","role":"organisation id","title":"ROR"},{"uri":"198706699","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"\u00e9valuer"},{"keyword":"impact"},{"keyword":"strat\u00e9gies immunosuppressives (IS)"},{"keyword":"transplant\u00e9s r\u00e9naux"},{"keyword":"Assurance Maladie"}],"topics":[{"topic":"N\u00e9phrologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009398"}]},{"topic":"Pr\u00e9sence d\u2019un organe ou de tissus greff\u00e9s","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/334236299","title":"CIM-11"}]}],"purpose":"L\u2019objectif principal de l\u2019\u00e9tude EPHEGREN est d\u2019\u00e9valuer l\u2019impact pharmaco-\u00e9conomique des diff\u00e9rentes strat\u00e9gies immunosuppressives (IS) chez les patients transplant\u00e9s r\u00e9naux du point de vue de l\u2019h\u00f4pital, de l\u2019Assurance Maladie et de la soci\u00e9t\u00e9. Les objectifs secondaires de l\u2019\u00e9tude EPHEGREN sont les suivants : Evaluer le rapport co\u00fbt-efficacit\u00e9 des diff\u00e9rentes strat\u00e9gies pr\u00e9ventives et curatives des r\u00e9activations et des maladies \u00e0 cytom\u00e9galovirus (CMV) chez les patients transplant\u00e9s r\u00e9naux CMV+ (statut s\u00e9rologique du receveur au moment de la greffe) du point de vue de l\u2019h\u00f4pital, de l\u2019Assurance Maladie et de la soci\u00e9t\u00e9. D\u00e9terminer les facteurs pharmacologiques pr\u00e9dictifs de l\u2019\u00e9volution \u00e0 long terme de la fonction r\u00e9nale. D\u00e9terminer les facteurs pharmacologiques pr\u00e9dictifs de la survenue de cancers, de diab\u00e8te, de pathologies cardiovasculaires. Valider l\u2019impact de polymorphismes g\u00e9n\u00e9tiques concernant les enzymes du m\u00e9tabolisme, transporteurs membranaires et les prot\u00e9ines cibles des immunosuppresseurs sur l\u2019exposition et les effets th\u00e9rapeutiques et secondaires du traitement. Valider prospectivement des candidats biomarqueurs urinaires de rejet aigu, actuels et \u00e0 venir, ou de dysfonction chronique du greffon r\u00e9nal.","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2017-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients majeurs, des deux sexes, dans leur 1er mois de greffe r\u00e9nale et capables de remplir les questionnaires de l\u2019\u00e9tude.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es socio-d\u00e9mographiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['eCRF d\u00e9velopp\u00e9 dans ENNOV CLINICA']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"829"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Au cas par cas, sur demande","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"21-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public 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