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<docDscr>
  <citation>
    <titlStmt>
      <titl>Impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with C.E.R.A</titl>
      <IDNo>FRESH-PEF74134-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="F. HOFFMANN-LA ROCHE AG" role="">Camille BACHOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with C.E.R.A            </titl>
      <altTitl>
                    MIRIADE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF74134-en            </IDNo>
      <IDNo agency="PEF">
                    74134                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF74134                </IDNo>
      <IDNo agency="NCT">
                    NCT01974271                </IDNo>
    </titlStmt>
    <rspStmt>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="F. HOFFMANN-LA ROCHE AG" email="dir8@impact-dev.tn">
                    ;Medical data center
                                            <ExtLink title="ROR" URI="https://ror.org/01mqmer16" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="775752140" role="organisation id"/>
                                    </contact>
      <depDate date="2026-05-25"/>
      <distDate date="2026-05-25"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo><studyBudget/><subject><keyword vocab="" vocabURI="">
                    MIRCERA®</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">
                        Healthcare system determinants: Use of care                    </topcClas><topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas></subject>

        Primary objective: To describe in CKD patients on dialysis the impact of comorbidities* on hemoglobin stability** after 6 months of treatment with Mircera® in routine clinical practice * Patients’ comorbidities will be analyzed on the basis of the CCI. ** Hemoglobin stability is defined as a variation of +/- 1g/dL of hemoglobin level between the first Mircera® injection and the 6th month of treatment, without red blood cells transfusion during this period. Secondary objectives: - In the overall study population and in each subgroup of patients defined by a range of the Charlson comorbidity index (&lt;=3, [4-5], [6-7], &gt;=8): - - To describe baseline characteristics of the patients; - - To describe the monthly changes in hemoglobin level; - - To describe monthly Mircera® dose. - To describe patients’ vital status and all adverse events over the observation period with Mircera®; - To describe the hemoglobin stability after 6 months of treatment with Mircera®, according to subgroups of Liu comorbidity index (&lt;=3; [4-6]; [7-9]; &gt;=10); - To describe the proportion of patients with an Hb level within the range 10-12 g/dL with or without hemoglobin stability after 6 months of treatment with Mircera®, according to the subgroups of Charlson and Liu comorbidity indexes.<abstract contentType="purpose">null</abstract>        <abstract contentType="abstract">null</abstract>
        <sumDscr><collDate event="start" date="2014-01-01"/><collDate event="end" date="2015-01-01"/><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">Inclusion criteria: - Patient aged 18 years or older;  - CKD patient on hemodialysis or hemodiafiltration for at least 3 months;  - Patient previously treated with an ESA; - Patient for whom the investigator decided to initiate a treatment with Mircera® for medical reasons;  - Patient with last hemoglobin level within the range [10  12] g/dL before Mircera® initiation; - Patient having received oral and written information about the study, without any objections for the use of his/her personal data, and having signed a written informed consent form.                      </universe><universe clusion="E">Patients participating in a clinical trial on renal anemia at inclusion were excluded from study entry.                    </universe><dataKind>Clinical data</dataKind><dataKind>Biological data</dataKind></sumDscr>
                
                    <qualityStatement><standardsCompliance><standard><standardName>CDISC</standardName></standard></standardsCompliance><otherQualityStatement>GCP/GVP</otherQualityStatement></qualityStatement>
        



        

    </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health care consumption and services</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>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>636</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
