{"doc_desc":{"title":"Impact des comorbidit\u00e9s sur la stabilit\u00e9 de l'h\u00e9moglobine chez les patients atteints de maladie r\u00e9nale chronique sous dialyse trait\u00e9s par m\u00e9thoxy poly\u00e9thyl\u00e8ne glycol-\u00e9po\u00e9tine b\u00eata (C.E.R.A.)","idno":"FRESH-PEF74134-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74134-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74134"},{"agency":"FReSH","code":"FRESH-PEF74134"},{"agency":"NCT","code":"NCT01974271"}]},"title":"Impact des comorbidit\u00e9s sur la stabilit\u00e9 de l'h\u00e9moglobine chez les patients atteints de maladie r\u00e9nale chronique sous dialyse trait\u00e9s par m\u00e9thoxy poly\u00e9thyl\u00e8ne glycol-\u00e9po\u00e9tine b\u00eata (C.E.R.A.)","alternate_title":"MIRIADE"},"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","email":"data_sharing.france@roche.com","type":"contact","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 l'impact des comorbidit\u00e9s* sur la stabilit\u00e9 de l'h\u00e9moglobine** apr\u00e8s 6 mois de traitement par Mircera\u00ae chez des patients atteints de maladie r\u00e9nale chronique et dialys\u00e9s, dans le cadre d'une pratique clinique courante. * Les comorbidit\u00e9s des patients seront analys\u00e9es sur la base de leur Indice de Comorbidit\u00e9 de Charlson (ICC). ** La stabilit\u00e9 de l'h\u00e9moglobine est d\u00e9finie comme une variation de +\/- 1g\/dL du taux d'h\u00e9moglobine entre la premi\u00e8re injection de Mircera\u00ae et le 6e mois de traitement, sans transfusion de globules rouges durant cette p\u00e9riode. Objectifs secondaires : - Dans la population globale de l'\u00e9tude et dans chaque sous-groupe de patients d\u00e9fini par une plage de l'indice de comorbidit\u00e9 de Charlson (<=3, [4-5], [6-7], >=8) : - D\u00e9crire les caract\u00e9ristiques de base des patients ; - D\u00e9crire les changements mensuels du taux d'h\u00e9moglobine ; - D\u00e9crire la dose mensuelle de Mircera\u00ae. - D\u00e9crire l'\u00e9tat vital des patients et tous les \u00e9v\u00e9nements ind\u00e9sirables survenus au cours de la p\u00e9riode d'observation avec Mircera\u00ae ; - D\u00e9crire la stabilit\u00e9 du taux d'h\u00e9moglobine apr\u00e8s 6 mois de traitement par Mircera\u00ae, selon les sous-groupes de l'indice de comorbidit\u00e9 de Liu (<=3 ; [4-6] ; [7-9] ; >=10) ; - D\u00e9crire la proportion de patients dont le taux d'h\u00e9moglobine se situe entre 10 et 12 g\/dL, avec ou sans stabilit\u00e9 de l'h\u00e9moglobine apr\u00e8s 6 mois de traitement par Mircera\u00ae, selon les sous-groupes des indices de comorbidit\u00e9 de Charlson et de Liu.","abstract":"","coll_dates":[{"start":"2014-01-01","end":"2015-01-01"}],"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 : - Patient \u00e2g\u00e9 de 18 ans ou plus ; - Patient atteint d'IRC sous h\u00e9modialyse ou h\u00e9modiafiltration depuis au moins 3 mois ; - Patient d\u00e9j\u00e0 trait\u00e9 avec un agent stimulant l'\u00e9rythropo\u00ef\u00e8se (ASE) ; - Patient pour lequel l'investigateur a d\u00e9cid\u00e9 d'initier un traitement avec Mircera\u00ae pour des raisons m\u00e9dicales ; - Patient dont le dernier taux d'h\u00e9moglobine se situait dans l'intervalle [10 12] g\\\/dL avant l'instauration du traitement par Mircera\u00ae ; - Patient ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude, sans objection quant \u00e0 l'utilisation de ses donn\u00e9es personnelles, et ayant sign\u00e9 un formulaire de consentement \u00e9clair\u00e9.  \",\n    \"clusion_E\": \"\"\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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[500-1000[ individus","response_rate":"636"},"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":"Non","contributorName":"Camille BACHOT","contributorAffiliation":"F. HOFFMANN-LA ROCHE AG","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Donn\u00e9es d\u00e9mographiques - Ant\u00e9c\u00e9dents de la maladie - Comorbidit\u00e9s - Biologie - Traitements an\u00e9miques ant\u00e9rieurs - Traitements an\u00e9miques concomitants - Effets ind\u00e9sirables.","biologicalDataDetails":"","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}