Clinical trial NCT02691546: Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)
Official title: Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Diseases
Older
Geriatric assessment
Biomarkers
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
name: Erasmus Medical Center
name: Medical University of Graz
name: Servicio Madrileño de Salud, Madrid, Spain
name: Institut Catala de Salut
name: UNIVERSYTET MEDYCZNY W LODZI
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Uppsala University
First posted: 2016-02-25
Enrollment: 2434
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with 75 years or older

Brief summary: The SCOPE study is an observational, multicenter, prospective cohort study aimed at evaluating a 2-year screening programme for CKD in a population of older patients, aged 75 years or more, in seven European Countries, in an attempt to investigate whether and to which extent currently available screening methods may identify older people at risk of worsening kidney function.


Eligibility criteria: Inclusion Criteria:

* age≥75 years
* subjects attending the outpatient services at participating institutions

Exclusion Criteria:

* ESRD or dialysis
* history of solid organ or bone marrow transplantation
* active malignancy within 24 months prior to screening or metastatic cancer
* life expectancy less than 6 months
* severe cognitive impairment (MMSE\<10),
* any medical or other reason that the subject is unsuitable for the study
* subjects unwilling to provide consent

Primary outcomes:
measure: Rate of estimated Glomerular Filtration Rate (eGFR) decline
timeFrame: 24 months
measure: Incidence of End Stage Renal Disease (ESRD)
timeFrame: 24 months
Secondary outcomes:
measure: Biomarkers of kidney function
timeFrame: Baseline and 24 months
measure: Genetic and epigenetic analyses
timeFrame: Baseline and 24 months
measure: Incidence of CKD complications
timeFrame: 24 months
measure: Incidence of major comorbidities
timeFrame: 24 months
measure: Cardiovascular mortality
timeFrame: 24 months
measure: Comprehensive geriatric assessment (CGA)
timeFrame: Baseline and 24 months
measure: Healthcare resource consumption
timeFrame: Baseline and 24 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department
city: Erlangen
country: Germany
facility: FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging
city: Beer Sheva
country: Israel
facility: BEN-GURION UNIVERSITY-Geriatrics 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: Lodz
country: Poland
facility: UNIVERSYTET MEDYCZNY-Department of Geriatrics
city: Barcelona
country: Spain
facility: INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment
city: Madrid
country: Spain
facility: SERVICIO MADRILENO DE SALUD-Geriatric Department
Study officials:
References:
citation: Freiberger E, Fabbietti P, Corsonello A, Lattanzio F, Artzi-Medvedik R, Kob R, Melzer I; SCOPE consortium; Britting S. Transient versus stable nature of fear of falling over 24 months in community-older persons with falls- data of the EU SCOPE project on Kidney function. BMC Geriatr. 2022 Aug 23;22(1):698. doi: 10.1186/s12877-022-03357-0.
citation: Tap L, Corsonello A, Formiga F, Moreno-Gonzalez R, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Ziere G, Freiberger E, Sieber C, Kostka T, Guligowska A, Gil P, Martinez SL, Artzi-Medvedik R, Yehoshua I, Fabbietti P, Lattanzio F, Mattace-Raso F; SCOPE investigators. Is kidney function associated with cognition and mood in late life? : The Screening for CKD among Older People across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):297. doi: 10.1186/s12877-020-01707-4.
citation: Britting S, Artzi-Medvedik R, Fabbietti P, Tap L, Mattace-Raso F, Corsonello A, Lattanzio F, Arnlov J, Carlsson AC, Roller-Wirnsberger R, Wirnsberger G, Kostka T, Guligowska A, Formiga F, Moreno-Gonzalez R, Gil P, Martinez SL, Kob R, Melzer I, Freiberger E; SCOPE investigators. Kidney function and other factors and their association with falls : The screening for CKD among older people across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):320. doi: 10.1186/s12877-020-01698-2.
citation: Corsonello A, Fabbietti P, Formiga F, Moreno-Gonzalez R, Tap L, Mattace-Raso F, Roller-Wirnsberger R, Wirnsberger G, Arnlov J, Carlsson AC, Weingart C, Freiberger E, Kostka T, Guligowska A, Gil P, Martinez SL, Melzer I, Yehoshua I, Lattanzio F; SCOPE investigators. Chronic kidney disease in the context of multimorbidity patterns: the role of physical performance : The screening for CKD among older people across Europe (SCOPE) study. BMC Geriatr. 2020 Oct 2;20(Suppl 1):350. doi: 10.1186/s12877-020-01696-4.
citation: Corsonello A, Tap L, Roller-Wirnsberger R, Wirnsberger G, Zoccali C, Kostka T, Guligowska A, Mattace-Raso F, Gil P, Fuentes LG, Meltzer I, Yehoshua I, Formiga-Perez F, Moreno-Gonzalez R, Weingart C, Freiberger E, Arnlov J, Carlsson AC, Bustacchini S, Lattanzio F; SCOPE investigators. Design and methodology of the screening for CKD among older patients across Europe (SCOPE) study: a multicenter cohort observational study. BMC Nephrol. 2018 Oct 11;19(1):260. doi: 10.1186/s12882-018-1030-2.