Screening for Chronic Kidney Disease among Older People across Europe (SCOPE)

Screening for Chronic Kidney Disease among Older People across Europe (SCOPE) - SCOPE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46292

Enrollment

350

Registered

2016-03-07

Start date

2016-08-10

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease End Stage Renal Disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients and their spouses aged 75 and over, attending the outpatient services at participating institutions.

Exclusion criteria

Exclusion criteria: Only patients with 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

Design outcomes

Primary

Measure	Time frame
The primary study endpoints will be the rate of eGFR decline and the incidence of ESRD. - Creatinine-based eGFR will be calculated using the Berlin Initiative Study 1 (BIS1) equation, which is the only method specifically developed in a population older than 70 years - ESRD will be defined as GFR	—

Secondary

Measure	Time frame
Secondary study endpoints include conventional and geriatric outcome measures, such as: i. kidney function decline as estimated by novel application of existing biomarkers (cystatin C, beta2-microglobulin, beta-trace protein) or innovative biomarkers (proteomic/metabolomic) (see following sections for details). ii. changes in biological and molecular markers linked to aging processes iii. CKD complications (anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia); iv. incidence of major comorbidities (information about CV events will include incident myocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis); v. overall and CV mortality (including death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes); vi. adverse drug reactions (ADRs); vii. self-reported disability and objectively measured physical performance decline; cognitive impairment; depression; malnutrition/undernutrition; viii. health-related quality of life; ix. healthcare resource consumption, including the estimation of caregiver burden, and model based cost-effectiveness.	—

Measure

Time frame

Secondary study endpoints include conventional and geriatric outcome measures, such as: i. kidney function decline as estimated by novel application of existing biomarkers (cystatin C, beta2-microglobulin, beta-trace protein) or innovative biomarkers (proteomic/metabolomic) (see following sections for details). ii. changes in biological and molecular markers linked to aging processes iii. CKD complications (anemia, hyperphosphatemia, acidosis, hypoalbuminemia, hyperparathyroidism, hyperkaliemia); iv. incidence of major comorbidities (information about CV events will include incident myocardial infarction, hospitalization for unstable angina, transient ischemic attack/stroke, heart failure events, interventional cardiology events, peripheral vascular intervention, and stent thrombosis); v. overall and CV mortality (including death resulting from acute myocardial infarction, sudden cardiac death, heart failure, stroke, CV procedures, CV hemorrhage, and other CV causes); vi. adverse drug reactions (ADRs); vii. self-reported disability and objectively measured physical performance decline; cognitive impairment; depression; malnutrition/undernutrition; viii. health-related quality of life; ix. healthcare resource consumption, including the estimation of caregiver burden, and model based cost-effectiveness.

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Countries

Netherlands

Outcome results