{"doc_desc":{"title":"\u00c9tude non interventionnelle visant \u00e0 \u00e9valuer le taux d'h\u00e9moglobine en fonction de l'indice de comorbidit\u00e9 chez les patients atteints de la maladie r\u00e9nale chronique (MRC) non dialys\u00e9s trait\u00e9s par Mircera\u00ae.","idno":"FRESH-PEF74126-fr","producers":[{"name":"Camille BACHOT","affiliation":"F. HOFFMANN-LA ROCHE AG"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF74126-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"74126"},{"agency":"FReSH","code":"FRESH-PEF74126"},{"agency":"NCT","code":"NCT01756612"}]},"title":"\u00c9tude non interventionnelle visant \u00e0 \u00e9valuer le taux d'h\u00e9moglobine en fonction de l'indice de comorbidit\u00e9 chez les patients atteints de la maladie r\u00e9nale chronique (MRC) non dialys\u00e9s trait\u00e9s par Mircera\u00ae.","alternate_title":"COMETE"},"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 primaire : D\u00e9crire en pratique m\u00e9dicale courante l'\u00e9volution des taux d'h\u00e9moglobine au cours des 9 mois de suivi dans chaque sous-groupe d\u00e9fini par l'indice de comorbidit\u00e9 de Charlson. Objectifs secondaires : - D\u00e9crire les caract\u00e9ristiques des patients trait\u00e9s par Mircera\u00ae dans la population totale et dans les sous-groupes d\u00e9finis par l'indice de comorbidit\u00e9 de Charlson ; - D\u00e9crire l'\u00e9volution du taux d'h\u00e9moglobine pendant la p\u00e9riode d'observation en fonction de l'indice de comorbidit\u00e9 de Liu et des facteurs de r\u00e9sistance aux ASE ; - D\u00e9crire l'\u00e9volution de la posologie de Mircera\u00ae pendant la p\u00e9riode d'observation dans la population totale et dans les sous-groupes d\u00e9finis par l'indice de comorbidit\u00e9 de Charlson ; - D\u00e9crire le profil d'innocuit\u00e9 de Mircera\u00ae pendant la p\u00e9riode d'observation dans la population totale et dans les sous-groupes d\u00e9finis par l'indice de comorbidit\u00e9 de Charlson.","abstract":"","coll_dates":[{"start":"2012-01-01","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 plus de 18 ans ; - Patient souffrant d'une maladie r\u00e9nale chronique non dialys\u00e9e ; - Patients na\u00effs d'ASE (n'ayant pas re\u00e7u d'ASE dans les 6 mois pr\u00e9c\u00e9dant l'inclusion) ; - Patients ayant un taux d'h\u00e9moglobine <10,0 g\\\/dL \u00e0 l'inclusion ; - Patients pour lesquels le m\u00e9decin traitant a d\u00e9cid\u00e9 d'initier un traitement avec Mircera\u00ae pour des raisons m\u00e9dicales avant le d\u00e9but de l'\u00e9tude ; - Patient ayant re\u00e7u des informations orales et \u00e9crites sur l'\u00e9tude, sans aucune objection quant \u00e0 l'utilisation de ses donn\u00e9es personnelles. \",\n    \"clusion_E\": \"Patients ayant subi une transplantation r\u00e9nale fonctionnelle ; - Patients participant \u00e0 un essai clinique sur l'an\u00e9mie due \u00e0 la MRC\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"['CDISC']","committee":"","governance":""}],"other_quality_statement":"['Bonnes pratiques de pharmacovigilance\/Bonnes pratiques cliniques']"}},"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"}]},"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":"550"},"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":"11-12-2024","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":"eCRF","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":""},"dataTypes":{"clinicalDataDetails":"Validation des crit\u00e8res d'inclusion et d'exclusion - Dates des visites (ou donn\u00e9es du dernier contact avec le patient) - Donn\u00e9es d\u00e9mographiques - Histoire et \u00e9volution de la MRC - Comorbidit\u00e9s - Donn\u00e9es cliniques et biologiques les plus r\u00e9centes - Traitements ant\u00e9rieurs et\/ou en cours de l'IRC - Autres traitements sp\u00e9cifiques - Traitements ant\u00e9rieurs et\/ou en cours de l'an\u00e9mie - Traitement par Micera\u00ae - Ev\u00e8nements ind\u00e9sirables - Raison de l'arr\u00eat pr\u00e9matur\u00e9 de l'\u00e9tude.","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"}