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

NCT04449172 | Completed

• 2 other identifiers: INRCA_05_2019Grant Agreement n. 634869
• Study Type: observational
• Target: 100
• Locations: 4 countries
• Sites: 5

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.

Conditions

Chronic Kidney Diseases

Keywords

glomerular filtration rate; older people; ioexol

Outcome Measures

Primary Outcomes (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

  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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• to be eligible for this study, subjects must have been enrolled in the SCOPE study

You may not qualify if:

• a thyroid-stimulating hormone level less than 0.3 mlU/L
• a known iodine allergy
• oedema
• ascites
• clinically symptomatic heart failure

Sponsors & Collaborators

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

Study Sites (5)

MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department

Graz, 8036, Austria

Location

INRCA Research Hospital

Ancona, 60131, Italy

Location

INRCA Research Hospital

Cosenza, Italy

Location

ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine

Rotterdam, 3015CE, Netherlands

Location

INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment

Barcelona, 08007, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma samples

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: August 8, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: March 5, 2024

Record last verified: 2020-06

Locations

ES (1); AU (1); IT (2); NL (1)