<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>Longitudinal Pharmacoeconomical Study on Kidney Transplantation Patients</titl>
      <IDNo>FRESH-PEF5209-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE DE LIMOGES" role="">Pierre MARQUET</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Longitudinal Pharmacoeconomical Study on Kidney Transplantation Patients            </titl>
      <altTitl>
                    EPHEGREN                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF5209-en            </IDNo>
      <IDNo agency="PEF">
                    5209                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF5209                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Marie ESSIG                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)">
        <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
        <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Pierre MARQUET                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE LIMOGES">
        <ExtLink title="ROR" URI="https://ror.org/02cp04407" role="organisation id"/>
        <ExtLink title="SIREN" URI="198706699" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            CENTRE HOSPITALIER ET UNIVERSITAIRE DE LIMOGES (CHU)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            CENTRE HOSPITALIER ET UNIVERSITAIRE DE LIMOGES (CHU)                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)" email="marie.essig@inserm.fr">
                    Marie;ESSIG
                                            <ExtLink title="ROR" URI="https://ror.org/00pg5jh14" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="267500452" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE DE LIMOGES" email="pierre.marquet@unilim.fr">
                    Pierre;MARQUET
                                            <ExtLink title="ROR" URI="https://ror.org/02cp04407" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="198706699" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    immunosuppressive strategies (IS)</keyword>
      <keyword vocab="" vocabURI="">
                    kidney transplants</keyword>
      <keyword vocab="" vocabURI="">
                    assessment</keyword>
      <keyword vocab="" vocabURI="">
                    impact</keyword>
      <keyword vocab="" vocabURI="">
                    health insurance</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">
                        Presence of transplanted organ or tissue                                            </topcClas>
    </subject>
    <abstract contentType="purpose">The main aim of the EPHEGREN study is to assess the pharmacoeconomic impact of different immunosuppressive strategies (IS) on kidney transplant patients from a hospital, health insurance and societal perspective. The secondary objectives of the EPHEGREN study: To assess the cost-effectiveness of different preventative and curative strategies for reactivation and cytomegalovirus (CMV) disease in CMV+ kidney transplant patients (serologic status of recipient when receiving transplant) from a hospital, health insurance and societal perspective. To determine predictive pharmacological factors for long-term renal function outcome. To determine predictive pharmacological factors for the onset of cancer, diabetes and cardiovascular diseases. To validate the impact of genetic polymorphisms on metabolic enzymes, membrane transporters and proteins targeting immunosuppressants on exposure and the therapeutic and side effects of treatment. To prospectively validate urinary biomarker candidates for current or future acute rejection, or for chronic renal allograft dysfunction.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2013-01-01"/>
      <collDate event="end" date="2017-01-01"/>
      <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 clusion="I">Adult patients of either sex during the first month of kidney transplantation who are able to complete the study questionnaire.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Socio-demographic data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>adverse events coded with MEDDRA</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>eCRF developped with ENNOV CLINICA</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 independent healthcare practitioners 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>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>1,000</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Conditions for access to the database is being defined.</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
