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ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study

Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani (Other)
Overall Status
Unknown status
CT.gov ID
NCT04449172
Collaborator
Erasmus Medical Center (Other), Institut Catala de Salut (Other), Medical University of Graz (Other)
140
Enrollment
5
Locations
14.8
Anticipated Duration (Months)
28
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study
    Actual Study Start Date :
    Aug 8, 2019
    Anticipated Primary Completion Date :
    Oct 30, 2020
    Anticipated Study Completion Date :
    Oct 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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 [300 minutes from intravenous injection of iohexol]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • to be eligible for this study, subjects must have been enrolled in the SCOPE study
    Exclusion Criteria for substudy:

    • a thyroid-stimulating hormone level less than 0.3 mlU/L

    • a known iodine allergy

    • oedema

    • ascites

    • clinically symptomatic heart failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department Graz Austria 8036
    2 INRCA Research Hospital Ancona Italy 60131
    3 INRCA Research Hospital Cosenza Italy
    4 ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine Rotterdam Netherlands 3015CE
    5 INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment Barcelona Spain 08007

    Sponsors and Collaborators

    • Istituto Nazionale di Ricovero e Cura per Anziani
    • Erasmus Medical Center
    • Institut Catala de Salut
    • Medical University of Graz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Nazionale di Ricovero e Cura per Anziani
    ClinicalTrials.gov Identifier:
    NCT04449172
    Other Study ID Numbers:
    • INRCA_05_2019
    • Grant Agreement n. 634869
    First Posted:
    Jun 26, 2020
    Last Update Posted:
    Jun 26, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Istituto Nazionale di Ricovero e Cura per Anziani
    glomerular filtration rate
    older people
    ioexol
    Additional relevant MeSH terms:
    Kidney Diseases
    Renal Insufficiency, Chronic

    Study Results

    No Results Posted as of Jun 26, 2020