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

Istituto Nazionale di Ricovero e Cura per Anziani2,434 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,434

Conditions

Chronic Kidney Diseases

Interventions

blood sample collectionOTHER

Eligibility

Sex: ALLMin age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (9)

MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department

Graz, Austria

FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging

Erlangen, Germany

BEN-GURION UNIVERSITY-Geriatrics Department

Beersheba, Israel

Outcomes

Primary Outcomes

Rate of estimated Glomerular Filtration Rate (eGFR) decline

eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation

Time frame: 24 months

Incidence of End Stage Renal Disease (ESRD)

ESRD will be defined as eGFR\<15 mL/min/1.73 m2 or dialysis

Time frame: 24 months

Secondary Outcomes

Biomarkers of kidney function

cystatin C, beta2-microglobulin, beta-trace protein

Time frame: Baseline and 24 months

Genetic and epigenetic analyses

circulating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome

Time frame: Baseline and 24 months

Incidence of CKD complications

anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia

Time frame: 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

Time frame: 24 months

Cardiovascular mortality

death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes

Time frame: 24 months

Comprehensive geriatric assessment (CGA)

Data from ClinicalTrials.gov

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