Screening for Chronic Kidney Disease (CKD) Among Older People Across Europe (SCOPE)
- Conditions
- Chronic Kidney Diseases
- Interventions
- Other: blood sample collection
- Registration Number
- NCT02691546
- Lead Sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2434
- age≥75 years
- subjects attending the outpatient services at participating institutions
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subjects aged 75 years or older blood sample collection -
- Primary Outcome Measures
Name Time Method Incidence of End Stage Renal Disease (ESRD) 24 months ESRD will be defined as eGFR\<15 mL/min/1.73 m2 or dialysis
Rate of estimated Glomerular Filtration Rate (eGFR) decline 24 months eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation
- Secondary Outcome Measures
Name Time Method Biomarkers of kidney function Baseline and 24 months cystatin C, beta2-microglobulin, beta-trace protein
Genetic and epigenetic analyses Baseline and 24 months circulating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome
Incidence of major comorbidities 24 months myocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis
Incidence of CKD complications 24 months anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia
Comprehensive geriatric assessment (CGA) Baseline and 24 months 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)
Healthcare resource consumption Baseline and 24 months previous physician visits, use of care services, hospital admissions, laboratory tests performed
Cardiovascular mortality 24 months death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes
Trial Locations
- Locations (8)
BEN-GURION UNIVERSITY-Geriatrics Department
🇮🇱Beer Sheva, Israel
FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging
🇩🇪Erlangen, Germany
INRCA Research Hospital
🇮🇹Cosenza, Italy
ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine
🇳🇱Rotterdam, Netherlands
UNIVERSYTET MEDYCZNY-Department of Geriatrics
🇵🇱Lodz, Poland
SERVICIO MADRILENO DE SALUD-Geriatric Department
🇪🇸Madrid, Spain
MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department
🇦🇹Graz, Austria
INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment
🇪🇸Barcelona, Spain