{"doc_desc":{"title":"Chronic Kidney Disease - Renal Epidemiology and Information Network","idno":"FRESH-PEF3087-en","producers":[{"name":"B\u00e9n\u00e9dicte STENGEL","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3087-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3087"},{"agency":"FReSH","code":"FRESH-PEF3087"}]},"title":"Chronic Kidney Disease - Renal Epidemiology and Information Network","alternate_title":"CKD-REIN"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"B\u00e9n\u00e9dicte;STENGEL","PILabo":"","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0001-9469-0804","role":"pi id"},{"title":"IdRef","uri":"087893452","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"","uri":"","role":"labo 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UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"sponsor id"},{"title":"SIREN","uri":"263305823","role":"sponsor id"}],"role":"sponsor"},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE AMIENS-PICARDIE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/010567a58","role":"sponsor id"},{"title":"SIREN","uri":"268000148","role":"sponsor id"}],"role":"sponsor"},{"name":"COMMISSARIAT A L' ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES (CEA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00jjx8s55","role":"sponsor id"},{"title":"SIREN","uri":"775685019","role":"sponsor id"}],"role":"sponsor"},{"name":"INSTITUT PASTEUR DE LILLE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05k9skc85","role":"sponsor id"},{"title":"SIREN","uri":"783696834","role":"sponsor id"}],"role":"sponsor"},{"name":"Arbor Research Collaborative for Health","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/043qmbk61","role":"sponsor id"}],"role":"sponsor"},{"name":"","extlink":[],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Elodie;SPEYER","email":"elodie.speyer@inserm.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"B\u00e9n\u00e9dicte;STENGEL","email":"benedicte.stengel@inserm.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"organization of care and cost-effectiveness of practices"},{"keyword":"Dialysis"},{"keyword":"quality of life"},{"keyword":"biomarkers"}],"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":"Chronic kidney disease","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/412389819","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The CKD-REIN cohort will provide a research platform to address key questions regarding a number of determinants and biomarkers associated with adverse CKD outcomes and to assess clinical practices and costs in patients selected at random from a representative sample of various types of nephrology consultations. In addition, it will meet the objectives of the starting international CKD Outcomes and Practice Patterns Study (CKDopps) designed principally to identify best treatment practices in patients with advanced CKD in several countries, including France. The objectives of the CKD-REIN study are: (1) to study a set of social, environmental, behavioral, clinical, and genetic factors, and their interactions in relation with the outcomes of CKD and its complications, including progression to ESRD and mortality, as well as the onset of several relevant acute and chronic clinical events : acute kidney injury, infections; cardiovascular diseases, cognitive decline, bone disease, and cancer ; (2) to assess several new biomarkers to predict adverse outcomes of CKD and its complications; (3) to evaluate the associations of provider practices (management of hypertension and of CKD complications such as anemia, nutritional abnormalities, and bone mineral disorder; timing of dialysis initiation and transplant wait-listing) with achievement of clinical practice guidelines, clinical outcomes (survival, ESRD, hospital admissions) and patient-reported outcomes (QoL, satisfaction). (4) to evaluate the associations of health care organization (e.g., multidisciplinary team, care network) and clinic services (e.g., for nutrition, educational programs) with clinical and patient-reported outcomes, and achievement of clinical practice guidelines; (5) to estimate the relative cost-effectiveness of different provider practices and clinic services. (6) to estimate the CKD incidence and prevalence in nephrology healthcare practices in France, depending on age, sex, social status, diabetes status, and depending on the stage and type of CKD.","abstract":"","coll_dates":[{"start":"2013-01-01","end":"2026-01-01"}],"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            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Study eligibility requires an eGFR < 60 mL\\\/min\\\/1.73 m2 for at least one month and no prior dialysis or transplantation. Inclusion criteria also requires less than 3 years of follow-up by the nephrology clinic for patients with CKD stage 3 in order to reduce survival bias due to prevalent cases. Patients <18 yrs old, pregnant, institutionalized, or unable to give inform consent are excluded, as well as patients who decline to participate.\",\n    \"clusion_E\": \", as well as patients who decline to participate.\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['CKD-REIN biobank received a bio-collection authorization from the French Ministry of Research, CODECOH n\u00b0 AC-2012-1624 based on the Picardie Biobank quality standard']"}},"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 organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"3033 patients"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort 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":"Accessibility of the database will be determined case by case by the governing board in agreement with the scientific committee. The IP and contractual issues will be examined by Inserm Transfert. Special attention will be paid on confidentiality, ethical issues and on the use of the biobank to yield the greatest scientific value to the community and avoid depletion of this finite resource.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":"Data collected about CKD patients, their sociodemographic characteristics, their environment and their treatments, the organization of health care system based on a representative sample of providers in the field of CKD, and the biobank will provide a unique research platform of major interest for a number of public and private organizations involved in the field of CKD research and patient care. CKD-REIN will encourage innovative projects and broad use of these data by external research groups or firms."}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"02-02-2012","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2025","isContributorPI":"No","contributorName":"B\u00e9n\u00e9dicte STENGEL","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/CKD-REIN"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)","Public (France)","Private non-profit","Other","Private non-profit"],"otherSponsorType":["","","","","","","","","","","","",""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":"Yes"},"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":"Data will be collected in 3 phases: 1- through medical records, from nephrologists and during annual face-to-face or telephone interviews; then each year through self-questionnaires sent home; Finally, data have been collected through French medico-administrative databases. 2- self-questionnaires sent home and 3- data collected exclusively through French medico-administrative databases.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"Nationwide cohort study in France, part of which is a component of an international study: the Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps)"},"dataTypes":{"clinicalDataDetails":"Demographics, cause of CKD. Medication categories: RAS antagonists, statins, phosphate binders, ESAs therapy. Nutrition: Prescribed restrictions of protein, potassium, sodium and phosphorus. RRT planning: Vascular access referral, placement","biologicalDataDetails":"Blood, urine, DNA, RNA samples","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}