<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>CHILDHOOD NEPHROTIC SYNDROME (2)</titl>
      <IDNo>FRESH-PEF5128-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)" role="">Georges DESCHNESE</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                CHILDHOOD NEPHROTIC SYNDROME (2)            </titl>
      <altTitl>
                    NEPHROVIR 2                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF5128-en            </IDNo>
      <IDNo agency="PEF">
                    5128                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF5128                </IDNo>
      <IDNo agency="NCT">
                    NCT01609426                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Georges DESCHENES                                                                                                                            </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="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Analysis</keyword>
      <keyword vocab="" vocabURI="">
                    immuno-virological status</keyword>
      <keyword vocab="" vocabURI="">
                    idiopathic</keyword>
      <keyword vocab="" vocabURI="">
                    corticosteroids</keyword>
      <keyword vocab="" vocabURI="">
                    B lymphocytes</keyword>
      <keyword vocab="" vocabURI="">
                    health episodes</keyword>
      <keyword vocab="" vocabURI="">
                    proteinuria</keyword>
      <keyword vocab="" vocabURI="">
                    glucocorticoids</keyword>
      <keyword vocab="" vocabURI="">
                    after-effect</keyword>
      <keyword vocab="" vocabURI="">
                    immunosuppressants</keyword>
      <keyword vocab="" vocabURI="">
                    Epstein Barr Virus (EBV)</keyword>
      <keyword vocab="" vocabURI="">
                    impact</keyword>
      <keyword vocab="" vocabURI="">
                    progression</keyword>
      <keyword vocab="" vocabURI="">
                    incidence</keyword>
      <keyword vocab="" vocabURI="">
                    recurrence</keyword>
      <keyword vocab="" vocabURI="">
                    complications</keyword>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <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">
                        Nephrotic syndrome                                            </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">To analyse the immuno-virological status of patients concerning Epstein Barr Virus (EBV) during the first manifestation of idiopathic nephrotic syndrome, and its impact on steroid therapy progression. A further study is proposed for the phenotypic characterisation and analysis of B lymphocytes in patients with relation to the EBV cycle.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <collDate event="end" date="2020-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogCover>Ile-de-France</geogCover>
      <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">Infant, Newborn (birth to 28 days)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007231"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant (28 days to 2 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007223"/>
                                                    </universe>
      <universe level="age" clusion="I">Child, Preschool (2 to 5 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002675"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </universe>
      <universe clusion="I">Children between 6 months and 15 years old, living in the Ile de France area, with first manifestation of idiopathic nephrotic syndrome defined as proteinuria higher than 50 mg/kg/day or proteinuria/creatinine higher than 0.25 g/mmol and hypoalbuminemia less than 30 g/L. Group 2: negative serology for hepatitis B and hepatitis C virus, no decrease in C3 component. Group 3: samples for hepatitis B virus, hepatitis C virus and C3 complement component serology.                    </universe>
      <universe clusion="E">Children not living in Ile de France at time of first manifestation are excluded.                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
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>&lt; 500 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>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>350</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
      <complete>Data may be used by industrial teams. Data may not be used by industrial teams.</complete>
    </setAvail>
    <useStmt>
      <restrctn>Contractual access.</restrctn>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
