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BMC Nephrology
Published in: BMC Nephrology 1/2018

Open Access 01-12-2018 | Study protocol

Design and methodology of the screening for CKD among older patients across Europe (SCOPE) study: a multicenter cohort observational study

Authors: Andrea Corsonello, Lisanne Tap, Regina Roller-Wirnsberger, Gerhard Wirnsberger, Carmine Zoccali, Tomasz Kostka, Agnieszka Guligowska, Francesco Mattace-Raso, Pedro Gil, Lara Guardado Fuentes, Itshak Meltzer, Ilan Yehoshua, Francesc Formiga-Perez, Rafael Moreno-González, Christian Weingart, Ellen Freiberger, Johan Ärnlöv, Axel C. Carlsson, Silvia Bustacchini, Fabrizia Lattanzio, on behalf of SCOPE investigators

Published in: BMC Nephrology | Issue 1/2018

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Abstract

Background

Decline of renal function is common in older persons and the prevalence of chronic kidney disease (CKD) is rising with ageing. CKD affects different outcomes relevant to older persons, additionally to morbidity and mortality which makes CKD a relevant health burden in this population. Still, accurate laboratory measurement of kidney function is under debate, since current creatinine-based equations have a certain degree of inaccuracy when used in the older population. The aims of the study are as follows: to assess kidney function in a cohort of 75+ older persons using existing methodologies for CKD screening; to investigate existing and innovative biomarkers of CKD in this cohort, and to align laboratory and biomarker results with medical and functional data obtained from this cohort. The study was registered at ClinicalTrials.gov, identifier NCT02691546, February 25th 2016.

Methods/design

An observational, multinational, multicenter, prospective cohort study in community dwelling persons aged 75 years and over, visiting the outpatient clinics of participating institutions. The study will enroll 2450 participants and is carried out in Austria, Germany, Israel, Italy, the Netherlands, Poland and Spain. Participants will undergo clinical and laboratory evaluations at baseline and after 12 and 24 months- follow-up. Clinical evaluation also includes a comprehensive geriatric assessment (CGA). Local laboratory will be used for ‘basic’ parameters (including serum creatinine and albumin-to-creatinine ratio), whereas biomarker assessment will be conducted centrally. An intermediate telephone follow-up will be carried out at 6 and 18 months.

Discussion

Combining the use of CGA and the investigation of novel and existing independent biomarkers within the SCOPE study will help to provide evidence in the development of European guidelines and recommendations in the screening and management of CKD in older people.

Trial registration

This study was registered prospectively on the 25th February 2016 at clinicaltrials.gov (NCT02691546).
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Metadata
Title
Design and methodology of the screening for CKD among older patients across Europe (SCOPE) study: a multicenter cohort observational study
Authors
Andrea Corsonello
Lisanne Tap
Regina Roller-Wirnsberger
Gerhard Wirnsberger
Carmine Zoccali
Tomasz Kostka
Agnieszka Guligowska
Francesco Mattace-Raso
Pedro Gil
Lara Guardado Fuentes
Itshak Meltzer
Ilan Yehoshua
Francesc Formiga-Perez
Rafael Moreno-González
Christian Weingart
Ellen Freiberger
Johan Ärnlöv
Axel C. Carlsson
Silvia Bustacchini
Fabrizia Lattanzio
on behalf of SCOPE investigators
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Nephrology / Issue 1/2018
Electronic ISSN: 1471-2369
DOI
https://doi.org/10.1186/s12882-018-1030-2

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