Chronic Kidney Diseases
Conditions
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Rate of estimated Glomerular Filtration Rate (eGFR) decline | 24 months | eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation |
| Incidence of End Stage Renal Disease (ESRD) | 24 months | ESRD will be defined as eGFR\<15 mL/min/1.73 m2 or dialysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of CKD complications | 24 months | anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia |
| 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 |
| Biomarkers of kidney function | Baseline and 24 months | cystatin C, beta2-microglobulin, beta-trace protein |
| 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 |
| Genetic and epigenetic analyses | Baseline and 24 months | circulating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome |
Countries
Austria, Germany, Israel, Italy, Netherlands, Poland, Spain