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

Chronic Kidney Diseases Clinical Trial

— SCOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691546
• Other study ID #: INRCA_01_2016
• Secondary ID: Grant Agreement
• Status: Completed
• Start date: August 8, 2016
• Est. completion date: March 10, 2020

Study information

• Verified date: February 2016
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2434
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• blood sample collection

Locations

Country	Name	City	State
Austria	MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department	Graz
Germany	FRIEDRICH-ALEXANDER-UNIVERSITAT-Institute for Biomedicine of Aging	Erlangen
Israel	BEN-GURION UNIVERSITY-Geriatrics Department	Beer Sheva
Italy	INRCA Research Hospital	Ancona
Italy	INRCA Research Hospital	Cosenza
Netherlands	ERASMUS UNIVERSITAIR MEDISCH CENTRUM-Department of Internal Medicine	Rotterdam
Poland	UNIVERSYTET MEDYCZNY-Department of Geriatrics	Lodz
Spain	INSTITUT CATALA DE LA SALUT-Internal Medicine Deparment	Barcelona
Spain	SERVICIO MADRILENO DE SALUD-Geriatric Department	Madrid

Sponsors (9)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani	Ben-Gurion University of the Negev, Erasmus Medical Center, FRIEDRICH-ALEXANDER-UNIVERSITAT ERLANGEN NURNBERG, Institut Catala de Salut, Medical University of Graz, Servicio Madrileño de Salud, Madrid, Spain, UNIVERSYTET MEDYCZNY W LODZI, UPPSALA UNIVERSITET

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of estimated Glomerular Filtration Rate (eGFR) decline	eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation	24 months
Primary	Incidence of End Stage Renal Disease (ESRD)	ESRD will be defined as eGFR<15 mL/min/1.73 m2 or dialysis	24 months
Secondary	Biomarkers of kidney function	cystatin C, beta2-microglobulin, beta-trace protein	Baseline and 24 months
Secondary	Genetic and epigenetic analyses	circulating microRNA, telomere length in circulating leukocytes, DNA methylation, analysis of the whole genome	Baseline and 24 months
Secondary	Incidence of CKD complications	anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia	24 months
Secondary	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
Secondary	Cardiovascular mortality	death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes	24 months
Secondary	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
Secondary	Healthcare resource consumption	previous physician visits, use of care services, hospital admissions, laboratory tests performed	Baseline and 24 months