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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Other: blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects aged 75 years or older<br> | Other: blood sample collection<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Diseases, Older, Geriatric assessment, Biomarkers