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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02691546
Acronym
SCOPE
Enrollment
2434
Registered
2016-02-25
Start date
2016-08-08
Completion date
2020-03-10
Last updated
2020-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Diseases, Older, Geriatric assessment, Biomarkers

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.

Interventions

OTHERblood sample collection

Sponsors

Ben-Gurion University of the Negev
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Medical University of Graz
CollaboratorOTHER
Servicio Madrileño de Salud, Madrid, Spain
CollaboratorOTHER
Institut Catala de Salut
CollaboratorOTHER_GOV
UNIVERSYTET MEDYCZNY W LODZI
CollaboratorUNKNOWN
Friedrich-Alexander-Universität Erlangen-Nürnberg
CollaboratorOTHER
Uppsala University
CollaboratorOTHER
Istituto Nazionale di Ricovero e Cura per Anziani
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of estimated Glomerular Filtration Rate (eGFR) decline24 monthseGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation
Incidence of End Stage Renal Disease (ESRD)24 monthsESRD will be defined as eGFR\<15 mL/min/1.73 m2 or dialysis

Secondary

MeasureTime frameDescription
Incidence of CKD complications24 monthsanemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia
Incidence of major comorbidities24 monthsmyocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis
Biomarkers of kidney functionBaseline and 24 monthscystatin C, beta2-microglobulin, beta-trace protein
Comprehensive geriatric assessment (CGA)Baseline and 24 monthsCognitive 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)
Healthcare resource consumptionBaseline and 24 monthsprevious physician visits, use of care services, hospital admissions, laboratory tests performed
Cardiovascular mortality24 monthsdeath resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes
Genetic and epigenetic analysesBaseline and 24 monthscirculating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome

Countries

Austria, Germany, Israel, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026