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Completed

NCT Number: NCT02691546

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MEDIZINISCHE UNIVERSITAT- Internal Medicine/Nephrology/Geriatric Department, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

Other

Primary outcomes

  1. Rate of estimated Glomerular Filtration Rate (eGFR) decline

    Time frame: 24 months

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

  2. Incidence of End Stage Renal Disease (ESRD)

    Time frame: 24 months

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

Secondary outcomes

  1. Biomarkers of kidney function

    Time frame: Baseline and 24 months

    cystatin C, beta2-microglobulin, beta-trace protein

  2. Genetic and epigenetic analyses

    Time frame: Baseline and 24 months

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

  3. Incidence of CKD complications

    Time frame: 24 months

    anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia

  4. Incidence of major comorbidities

    Time frame: 24 months

    myocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis

  5. Cardiovascular mortality

    Time frame: 24 months

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

  6. Comprehensive geriatric assessment (CGA)

    Time frame: 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)

  7. Healthcare resource consumption

    Time frame: Baseline and 24 months

    previous physician visits, use of care services, hospital admissions, laboratory tests performed

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Collaborators

  • Ben-Gurion University of the Negev
  • Erasmus Medical Center
  • Friedrich-Alexander-Universität Erlangen-Nürnberg
  • Institut Catala de Salut
  • Medical University of Graz
  • Servicio Madrileño de Salud, Madrid, Spain
  • UNIVERSYTET MEDYCZNY W LODZI
  • Uppsala University

Registry information

Acronym: SCOPE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2016
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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