<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04449172</url>
  </required_header>
  <id_info>
    <org_study_id>INRCA_05_2019</org_study_id>
    <secondary_id>Grant Agreement n. 634869</secondary_id>
    <nct_id>NCT04449172</nct_id>
  </id_info>
  <brief_title>ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study</brief_title>
  <acronym>SCOPE-PLUS</acronym>
  <official_title>ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Nazionale di Ricovero e Cura per Anziani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut Catala de Salut</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Nazionale di Ricovero e Cura per Anziani</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SCOPE-PLUS is an optional substudy of the observational SCOPE Study (Screening for Chronic&#xD;
      Kidney Disease among Older People across Europe, NCT02691546). The objective of the&#xD;
      SCOPE-PLUS study is to derive new equations based on innovative and novel biomarkers of CKD&#xD;
      function and compare its accuracy to measure GFR in the population older than 75 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SCOPE-PLUS is an optional substudy of the SCOPE cohort study (Screening for Chronic Kidney&#xD;
      Disease among Older People across Europe, NCT02691546). SCOPE has retrieved data on a wide&#xD;
      panel of biomarkers of CKD in a large study cohort enrolling about 2,450 older people in&#xD;
      Italy, Spain, Germany, Austria, Netherlands, Poland and Israel. The innovative biomarkers&#xD;
      have been already validated by the literature, and include e.g. Cystatin C (CysC), β-Trace&#xD;
      protein (BTP), and Beta2-microglobulin. Others promising novel biomarkers of CKD, based on&#xD;
      metabolomic and proteomic determinations or other techniques have been evaluated. The&#xD;
      objective of the SCOPE-plus study is to to verify the accuracy of newly developed equations&#xD;
      based on innovative and novel biomarkers of CKD function by calculating the percentage of&#xD;
      estimates within 30% (P30) of the measured GFR (mGFR). The mGFR will be obtained by the&#xD;
      assessment of nonradioactive iohexol clearance. Patients previously enrolled in the SCOPE&#xD;
      study, are invited to participate in this additional protocol. Iohexol is an iodinated&#xD;
      contrast medium with characteristics similar to those of inulin, being freely filtered by the&#xD;
      glomerulus, neither secreted nor reabsorbed by the renal tubules and recovered almost 100% in&#xD;
      the urine. These characteristics made it an ideal agent for the determination of the renal&#xD;
      function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 8, 2019</start_date>
  <completion_date type="Anticipated">October 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To measure GFR in subjects aged 75 or older by iohexol clearance to verify the accuracy of equations of innovative and novel biomarkers of CKD newly evaluated in the SCOPE study</measure>
    <time_frame>300 minutes from intravenous injection of iohexol</time_frame>
    <description>Iohexol solution 5 mL (Omnipaque, GE Healthcare), containing 3235 mg of iohexol will be administered intravenously into an antecubital, forearm, or hand vein and flushed with 10 mL of normal saline. Blood samples for serum creatinine and other biomarkers will be obtained before iohexol is applied. Blood samples will be obtained after 5 minutes from the contralateral arm to confirm that the Iohexol has been administered correctly intravenously. Subsequent blood sample will be collected (always from the contralateral arm) at 10, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes after injection. The exact timing of the samples collection will be recorded. All clearance measurements will be started between 8:00 and 10:30 a.m.</description>
  </primary_outcome>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and plasma samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        subjects with 75 years or older previously enrolled in the SCOPE study (NCT02691546)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  to be eligible for this study, subjects must have been enrolled in the SCOPE study&#xD;
&#xD;
        Exclusion Criteria for substudy:&#xD;
&#xD;
          -  a thyroid-stimulating hormone level less than 0.3 mlU/L&#xD;
&#xD;
          -  a known iodine allergy&#xD;
&#xD;
          -  oedema&#xD;
&#xD;
          -  ascites&#xD;
&#xD;
          -  clinically symptomatic heart failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>GERHARD WIRNSBERGER</last_name>
      <phone>0043 316 385 80</phone>
      <email>gerhard.wirnsberger@medunigraz.at</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>INRCA Research Hospital</name>
      <address>
        <city>Ancona</city>
        <zip>60131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabrizia Lattanzio</last_name>
      <phone>0039 0718004622</phone>
      <email>f.lattanzio@inrca.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>INRCA Research Hospital</name>
      <address>
        <city>Cosenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Corsonello</last_name>
      <phone>0039 0984682343</phone>
      <email>a.corsonello@inrca.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Mattace Raso</last_name>
      <phone>0031 10 703 59 79</phone>
      <email>f.mattaceraso@erasmusmc.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment</name>
      <address>
        <city>Barcelona</city>
        <zip>08007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>FRANCESC FORRMIGA</last_name>
      <phone>0034 93 260 7419</phone>
      <email>fformiga@bellvitgehospital.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glomerular filtration rate</keyword>
  <keyword>older people</keyword>
  <keyword>ioexol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04449172
org study id: INRCA_05_2019
secondary id: Grant Agreement n. 634869
nct id: NCT04449172
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SCOPE-PLUS is an optional substudy of the observational SCOPE Study (Screening for Chronic
      Kidney Disease among Older People across Europe, NCT02691546). The objective of the
      SCOPE-PLUS study is to derive new equations based on innovative and novel biomarkers of CKD
      function and compare its accuracy to measure GFR in the population older than 75 years.
SCOPE-PLUS is an optional substudy of the SCOPE cohort study (Screening for Chronic Kidney
      Disease among Older People across Europe, NCT02691546). SCOPE has retrieved data on a wide
      panel of biomarkers of CKD in a large study cohort enrolling about 2,450 older people in
      Italy, Spain, Germany, Austria, Netherlands, Poland and Israel. The innovative biomarkers
      have been already validated by the literature, and include e.g. Cystatin C (CysC), β-Trace
      protein (BTP), and Beta2-microglobulin. Others promising novel biomarkers of CKD, based on
      metabolomic and proteomic determinations or other techniques have been evaluated. The
      objective of the SCOPE-plus study is to to verify the accuracy of newly developed equations
      based on innovative and novel biomarkers of CKD function by calculating the percentage of
      estimates within 30% (P30) of the measured GFR (mGFR). The mGFR will be obtained by the
      assessment of nonradioactive iohexol clearance. Patients previously enrolled in the SCOPE
      study, are invited to participate in this additional protocol. Iohexol is an iodinated
      contrast medium with characteristics similar to those of inulin, being freely filtered by the
      glomerulus, neither secreted nor reabsorbed by the renal tubules and recovered almost 100% in
      the urine. These characteristics made it an ideal agent for the determination of the renal
      function.
observational model: Cohort
time perspective: Cross-Sectional
measure: To measure GFR in subjects aged 75 or older by iohexol clearance to verify the accuracy of equations of innovative and novel biomarkers of CKD newly evaluated in the SCOPE study
time frame: 300 minutes from intravenous injection of iohexol
description: Iohexol solution 5 mL (Omnipaque, GE Healthcare), containing 3235 mg of iohexol will be administered intravenously into an antecubital, forearm, or hand vein and flushed with 10 mL of normal saline. Blood samples for serum creatinine and other biomarkers will be obtained before iohexol is applied. Blood samples will be obtained after 5 minutes from the contralateral arm to confirm that the Iohexol has been administered correctly intravenously. Subsequent blood sample will be collected (always from the contralateral arm) at 10, 20, 30, 45, 60, 90, 120, 180, 240 and 300 minutes after injection. The exact timing of the samples collection will be recorded. All clearance measurements will be started between 8:00 and 10:30 a.m.
serum and plasma samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Austria
country: Italy
country: Netherlands
country: Spain
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic