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

March 4, 2024 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department
  • Italy
      • Ancona, Italy, 60131
        • INRCA Research Hospital
      • Cosenza, Italy
        • INRCA Research Hospital
  • Netherlands
      • Rotterdam, Netherlands, 3015CE
        • ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine
  • Spain
      • Barcelona, Spain, 08007
        • INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

subjects with 75 years or older previously enrolled in the SCOPE study (NCT02691546)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
300 minutes from intravenous injection of iohexol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Collaborators

Medical University of Graz
Erasmus Medical Center
Institut Catala de Salut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

June 23, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 26, 2020

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_05_2019
  • Grant Agreement n. 634869 (Other Grant/Funding Number: European Commission)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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