Clinical trial NCT04449172: ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study
Official title: ProtocoL for GFR Measurement Using Iohexol (SCOPE-PLUS) - A Substudy of the SCOPE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: glomerular filtration rate
older people
ioexol
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Institut Catala de Salut
name: Medical University of Graz
First posted: 2020-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with 75 years or older previously enrolled in the SCOPE study (NCT02691546)

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 300 minutes from intravenous injection of iohexol
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department
city: Ancona
country: Italy
facility: INRCA Research Hospital
city: Cosenza
country: Italy
facility: INRCA Research Hospital
city: Rotterdam
country: Netherlands
facility: ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine
city: Barcelona
country: Spain
facility: INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment
Study officials:
References: