<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF3087-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Chronic Kidney Disease - Renal Epidemiology and Information Network</titl>
      <IDNo>FRESH-PEF3087-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Bénédicte STENGEL</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Chronic Kidney Disease - Renal Epidemiology and Information Network            </titl>
      <altTitl>
                    CKD-REIN                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3087-en            </IDNo>
      <IDNo agency="PEF">
                    3087                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3087                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Bénédicte STENGEL                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)">
        <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
        <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="The Chronic Kidney Disease Outcomes and Practice Patterns Study (CKDopps) ISN iNET-CKD (International Network of Chronic Kidney Disease cohort studies) CHRONIC KIDNEY DISEASE PROGNOSIS CONSORTIUM (CKD-PC) CHRONIC KIDNEY DISEASE Genetic (CKD Gen) German CHRONIC KIDNEY DISEASE (German CKD)." type="collaboration">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            UNIVERSITE LYON 3 JEAN MOULIN                    
                                    </producer>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE NANCY                    
                                    </producer>
      <producer role="sponsor">
                                            ETABLISSEMENT FRANCAIS DU SANG (EFS)                    
                                    </producer>
      <producer role="sponsor">
                                            UNIVERSITE PARIS-SACLAY                    
                                    </producer>
      <producer role="sponsor">
                                            AGENCE DE LA BIOMEDECINE                    
                                    </producer>
      <producer role="sponsor">
                                            UNIVERSITE CLAUDE BERNARD LYON 1                    
                                    </producer>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX                    
                                    </producer>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER UNIVERSITAIRE AMIENS-PICARDIE                    
                                    </producer>
      <producer role="sponsor">
                                            COMMISSARIAT A L&amp;#039; ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES (CEA)                    
                                    </producer>
      <producer role="sponsor">
                                            INSTITUT PASTEUR DE LILLE                    
                                    </producer>
      <producer role="sponsor">
                                            Arbor Research Collaborative for Health                    
                                    </producer>
      <producer role="sponsor">
                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="elodie.speyer@inserm.fr">
                    Elodie;SPEYER
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
                                    </contact>
      <contact affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" email="benedicte.stengel@inserm.fr">
                    Bénédicte;STENGEL
                                            <ExtLink title="ROR" URI="https://ror.org/02vjkv261" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="180036048" role="organisation id"/>
                                    </contact>
      <depDate date="2026-05-07"/>
      <distDate date="2026-05-07"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    organization of care and cost-effectiveness of practices</keyword>
      <keyword vocab="" vocabURI="">
                    Dialysis</keyword>
      <keyword vocab="" vocabURI="">
                    quality of life</keyword>
      <keyword vocab="" vocabURI="">
                    biomarkers</keyword>
      <topcClas vocab="health theme">
                        Nephrology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/3961e9d2-ab3b-451b-b246-20fc0ec3b0c4"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009398"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Chronic kidney disease                                            </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants: Genetic predisposition                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Biological determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="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>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2013-01-01"/>
      <collDate event="end" date="2026-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Study eligibility requires an eGFR &lt; 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 &lt;18 yrs old, pregnant, institutionalized, or unable to give inform consent are excluded, as well as patients who decline to participate.                    </universe>
      <universe clusion="E">, as well as patients who decline to participate.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>CKD-REIN biobank received a bio-collection authorization from the French Ministry of Research</otherQualityStatement>
      <otherQualityStatement>CODECOH n° AC-2012-1624 based on the Picardie Biobank quality standard</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
      <sources>
        <sources>
          <sourceCitation>
                                    
                                    
                                                                    </sourceCitation>
          <srcOrig>Medico-administrative database</srcOrig>
        </sources>
      </sources>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>3033 patients</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <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.</conditions>
    </useStmt>
    <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.</notes>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
