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

NCT ID: NCT04449172

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-08
• Study Completion Date: 2021-08-30

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.

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Institut Catala de Salut

OTHER_GOV

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department

Graz, , Austria

INRCA Research Hospital

Ancona, , Italy

INRCA Research Hospital

Cosenza, , Italy

ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine

Rotterdam, , Netherlands

INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment

Barcelona, , Spain

Countries

Austria; Italy; Netherlands; Spain

Other Identifiers

Grant Agreement n. 634869

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

INRCA_05_2019

Identifier Type: -

Identifier Source: org_study_id