{"doc_desc":{"title":"\u00c9tude de cohorte chez des patients dialys\u00e9s atteints de maladie r\u00e9nale chronique qui commencent un traitement avec Mircera\u00ae pour corriger l'an\u00e9mie ou maintenir des taux d'h\u00e9moglobine stables","idno":"FRESH-PEF74133-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74133-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74133"},{"agency":"FReSH","code":"FRESH-PEF74133"},{"agency":"NCT","code":"NCT01213485"}]},"title":"\u00c9tude de cohorte chez des patients dialys\u00e9s atteints de maladie r\u00e9nale chronique qui commencent un traitement avec Mircera\u00ae pour corriger l'an\u00e9mie ou maintenir des taux d'h\u00e9moglobine stables","alternate_title":"HORTENSIA"},"study_authorization":{"agency":[{"name":"Autre"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":";Medical data center","lastname":"Medical data center","firstname":"","type":"contact","email":"data_sharing.france@roche.com","affiliationName":"F. HOFFMANN-LA ROCHE AG","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01mqmer16","role":"organisation id","title":"ROR"},{"uri":"775752140","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"MIRCERA\u00ae"}],"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":"Maladie r\u00e9nale chronique","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/412389819","title":"CIM-11"}]},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif principal : D\u00e9crire la prise en charge du traitement de l'an\u00e9mie par Mircera\u00ae dans la pratique clinique courante chez les patients atteints de maladie r\u00e9nale chronique et dialys\u00e9s, et d\u00e9crire leur concentration en h\u00e9moglobine autour du 6\u1d49 mois de traitement par Mircera\u00ae. Objectif secondaire : Dans la population totale et dans chaque sous-population de patients (h\u00e9modialyse et dialyse p\u00e9riton\u00e9ale, patients na\u00effs d'agents stimulants de l'\u00e9rythropo\u00ef\u00e8se (ASE) et non na\u00effs d'agents stimulants de l'\u00e9rythropo\u00ef\u00e8se (ASE)) : 1. D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s avec Mircera\u00ae ; 2. D\u00e9crire l'\u00e9volution des taux d'Hb et d'h\u00e9matocrite pendant la p\u00e9riode d'observation ; 3. D\u00e9crire les param\u00e8tres biologiques utilis\u00e9s pour documenter l'an\u00e9mie r\u00e9nale et tout changement dans les valeurs ; 4. D\u00e9crire les param\u00e8tres influen\u00e7ant la r\u00e9ponse au traitement ; 5. D\u00e9crire les param\u00e8tres biologiques refl\u00e9tant l'efficacit\u00e9 de la dialyse ; 6. D\u00e9crire le profil d'innocuit\u00e9 de Mircera\u00ae (effets ind\u00e9sirables graves et\/ou inattendus et effets ind\u00e9sirables cibl\u00e9s li\u00e9s \u00e0 Mircera\u00ae) ; 7. D\u00e9crire l'observance du traitement par Mircera\u00ae ; 8. D\u00e9crire l'\u00e9volution de la qualit\u00e9 de vie des patients, \u00e9valu\u00e9e par le questionnaire SF-36.","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2011-01-01"}],"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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Crit\u00e8res d'inclusion : - Adulte (\u00e2g\u00e9 de >= 18 ans) ; - Atteint de maladie r\u00e9nale chronique et sous dialyse depuis plus de 3 mois ; - Na\u00eff d'ASE ou non ; - Pour qui le m\u00e9decin a d\u00e9cid\u00e9 d'initier un traitement par Mircera\u00ae pour l'an\u00e9mie r\u00e9nale lors de la visite d'inclusion ; - Les personnes qui ont \u00e9t\u00e9 inform\u00e9es de l'\u00e9tude oralement et par \u00e9crit et qui ne se sont pas oppos\u00e9es au traitement de leurs donn\u00e9es personnelles.  \",\n    \"clusion_E\": \"Patient participant \u00e0 une \u00e9tude clinique ; - An\u00e9mie due \u00e0 une maladie maligne\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques cliniques\/Bonnes Pratiques de Pharmacovigilance (GCP\/GVP)']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Consommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"414"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"","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":"23-06-2022","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":true},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"papier","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Patients ont re\u00e7u l'information concernant l'\u00e9tude - Donn\u00e9es d\u00e9mographiques et cliniques, maladies concomitantes - Ant\u00e9c\u00e9dents de maladie r\u00e9nale chronique et de dialyse - Traitement ant\u00e9rieur de l'an\u00e9mie associ\u00e9e \u00e0 la maladie r\u00e9nale chronique : avec les agents stimulants de l'\u00e9rythropo\u00ef\u00e8se (ASE) le cas \u00e9ch\u00e9ant et autres traitements potentiels (fer, acide folique, vitamine B12, transfusion sanguine au cours des 3 derniers mois avant le d\u00e9but de Mircera\u00ae) - Donn\u00e9es cliniques lors de la s\u00e9ance de dialyse en milieu de semaine : poids apr\u00e8s la s\u00e9ance, tension art\u00e9rielle au repos et apr\u00e8s la s\u00e9ance - Donn\u00e9es de laboratoire les plus r\u00e9centes disponibles : ur\u00e9e et cr\u00e9atinine s\u00e9rique (avant et apr\u00e8s la s\u00e9ance de dialyse), ratio de r\u00e9duction de l'ur\u00e9e, Kt\/V (h\u00e9modialyse), Kt\/V total (dialyse p\u00e9riton\u00e9ale), Hb, h\u00e9matocrite, num\u00e9ration plaquettaire, r\u00e9ticulocytes, statut en fer, prot\u00e9ine C-r\u00e9active, carence document\u00e9e en acide folique ou en vitamine B12, le cas \u00e9ch\u00e9ant - Traitement de l'an\u00e9mie associ\u00e9e \u00e0 la maladie r\u00e9nale chronique au moment de l'inclusion : traitement par Mircera\u00ae et traitement concomitant le cas \u00e9ch\u00e9ant (fer, acide folique, vitamine B12) - Autres traitements : antihypertenseurs, antiplaquettaires, anticoagulants, h\u00e9parines de bas poids mol\u00e9culaires (HBPM) , traitements hypolipid\u00e9miants, antidiab\u00e9tiques, immunosuppresseurs.","biologicalDataDetails":"","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}