{"doc_desc":{"title":"Longitudinal Pharmacoeconomical Study on Kidney Transplantation Patients","idno":"FRESH-PEF5209-en","producers":[{"name":"Pierre MARQUET","affiliation":"UNIVERSITE DE LIMOGES"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF5209-en","IDno":{"metadata_no":[{"agency":"PEF","code":"5209"},{"agency":"FReSH","code":"FRESH-PEF5209"}]},"title":"Longitudinal Pharmacoeconomical Study on Kidney Transplantation Patients","alternate_title":"EPHEGREN"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Marie;ESSIG","PILabo":"","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0002-2030-5616","role":"pi id"},{"title":"IdRef","uri":"135266165","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"marie.essig@inserm.fr","isContact":"Yes"},{"type":"investigator","name":"Pierre;MARQUET","PILabo":"","affiliationName":"UNIVERSITE DE LIMOGES","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"198706699","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"pierre.marquet@unilim.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"marie.essig@inserm.fr","type":"contact","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","email":"pierre.marquet@unilim.fr","type":"contact","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":"immunosuppressive strategies (IS)"},{"keyword":"kidney transplants"},{"keyword":"assessment"},{"keyword":"impact"},{"keyword":"health insurance"}],"topics":[{"topic":"Nephrology","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":"Presence of transplanted organ or tissue","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/334236299","title":"CIM-11"}]}],"purpose":"The main aim of the EPHEGREN study is to assess the pharmacoeconomic impact of different immunosuppressive strategies (IS) on kidney transplant patients from a hospital, health insurance and societal perspective. The secondary objectives of the EPHEGREN study: To assess the cost-effectiveness of different preventative and curative strategies for reactivation and cytomegalovirus (CMV) disease in CMV+ kidney transplant patients (serologic status of recipient when receiving transplant) from a hospital, health insurance and societal perspective. To determine predictive pharmacological factors for long-term renal function outcome. To determine predictive pharmacological factors for the onset of cancer, diabetes and cardiovascular diseases. To validate the impact of genetic polymorphisms on metabolic enzymes, membrane transporters and proteins targeting immunosuppressants on exposure and the therapeutic and side effects of treatment. To prospectively validate urinary biomarker candidates for current or future acute rejection, or for chronic renal allograft dysfunction.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adult patients of either sex during the first month of kidney transplantation who are able to complete the study questionnaire.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Socio-demographic data']","quality_statement":{"standards":[{"name":"['adverse events coded with MEDDRA']","committee":"","governance":""}],"other_quality_statement":"['eCRF developped with ENNOV CLINICA']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[500-1000[ individuals","response_rate":"1,000"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Conditions for access to the database is being defined.","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"21-12-2012","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2025","isContributorPI":"No","contributorName":"Pierre MARQUET","contributorAffiliation":"UNIVERSITE DE LIMOGES","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"In the patient medical file and from a patient questionnaire: on observance, adverse effects and quality of life, and socio-demographic datas","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"6 hospitals (Limoges, Bordeaux, Toulouse, Rouen, Poitiers and Amiens)."},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}