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Clinical Trials/NCT02691546
NCT02691546
Completed
Not Applicable

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

Istituto Nazionale di Ricovero e Cura per Anziani8 sites in 7 countries2,434 target enrollmentAugust 8, 2016
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ConditionsChronic Kidney Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Enrollment
2434
Locations
8
Primary Endpoint
Incidence of End Stage Renal Disease (ESRD)
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
August 8, 2016
End Date
March 10, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Rate of estimated Glomerular Filtration Rate (eGFR) decline

Time Frame: 24 months

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

Secondary Outcomes

  • Biomarkers of kidney function(Baseline and 24 months)
  • Genetic and epigenetic analyses(Baseline and 24 months)
  • Incidence of major comorbidities(24 months)
  • Incidence of CKD complications(24 months)
  • Comprehensive geriatric assessment (CGA)(Baseline and 24 months)
  • Healthcare resource consumption(Baseline and 24 months)
  • Cardiovascular mortality(24 months)

Study Sites (8)

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