Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE) (SCOPE)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: blood sample collection

• Study Type: Observational
• Enrollment (Actual): 2434

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department
• Germany
  • Erlangen, Germany, 91054
    • FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging
• Israel
  • Beer Sheva, Israel, 84105
    • BEN-GURION UNIVERSITY-Geriatrics Department
• Italy
  • Ancona, Italy, 60131
    • INRCA Research Hospital
  • Cosenza, Italy
    • INRCA Research Hospital
• Netherlands
  • Rotterdam, Netherlands, 3015CE
    • ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine
• Poland
  • Lodz, Poland, 90419
    • UNIVERSYTET MEDYCZNY-Department of Geriatrics
• Spain
  • Barcelona, Spain, 08007
    • INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment
  • Madrid, Spain, 28020
    • SERVICIO MADRILENO DE SALUD-Geriatric Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

subjects with 75 years or older

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects aged 75 years or older	Other: blood sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of estimated Glomerular Filtration Rate (eGFR) decline	eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation	24 months
Incidence of End Stage Renal Disease (ESRD)	ESRD will be defined as eGFR<15 mL/min/1.73 m2 or dialysis	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of kidney function	cystatin C, beta2-microglobulin, beta-trace protein	Baseline and 24 months
Genetic and epigenetic analyses	circulating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome	Baseline and 24 months
Incidence of CKD complications	anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia	24 months
Incidence of major comorbidities	myocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis	24 months
Cardiovascular mortality	death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes	24 months
Comprehensive geriatric assessment (CGA)	Cognitive function (Mini Mental State Examination), depression (Geriatric Depression Scale), functional assessment (Basic Activity of Daily Living, Lawton Instrumental Activities of Daily Living Scale), health status (Cumulative Illness Rating Scale for Geriatrics), risk of malnutrition (Mini Nutritional Assessment), dietary intake assessment (24-h Dietary Recall), history of falls and incident falls, vision and hearing impairment, socioeconomic Status, physical Performance (Short Physical Performance Battery Test), muscle strength (Hand Grip Strength), quality of life (Euro-Qol 5D)	Baseline and 24 months
Healthcare resource consumption	previous physician visits, use of care services, hospital admissions, laboratory tests performed	Baseline and 24 months

Collaborators and Investigators

• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
• Collaborators: Medical University of Graz; Uppsala University; Erasmus Medical Center; Ben-Gurion University of the Negev; Institut Catala de Salut; Servicio Madrileño de Salud, Madrid, Spain; Friedrich-Alexander-Universität Erlangen-Nürnberg; UNIVERSYTET MEDYCZNY W LODZI

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2016
• Primary Completion (Actual): March 10, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: February 20, 2016
• First Submitted That Met QC Criteria: February 20, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Biomarkers; Older; Chronic Kidney Diseases; Geriatric assessment
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: INRCA_01_2016; Grant Agreement n. 634869 (Other Grant/Funding Number: European Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO