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Screening for Albuminuria at the First Line for Early Identification of CKD

Screening for Albuminuria at the First Line for Early Identification of Chronic Kidney Disease: a Pilot Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05321095
Acronym
SALINE
Enrollment
141
Registered
2022-04-11
Start date
2021-11-25
Completion date
2024-07-30
Last updated
2024-08-09

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

Conditions

Albuminuria, Chronic Kidney Diseases

Brief summary

Early detection of kidney disease

Detailed description

Early detection and appropriate treatment of kidney disease is important as this may prevent future cardiovascular complications and end-organ damage more effectively than intervention in more advanced stages of disease. There is a well-established relationship between albuminuria and renal- and cardiovascular disease. Elevated albuminuria has a relatively high prevalence in the general population (5-9%). The prevalence of albuminuria is even higher in high-risk patients with diabetes Mellitus, hypertension, obesity, cardiovascular disease and lipid disorders. Adequate treatment of albuminuria, preferable at early stages can prevent both cardiovascular and renal disease progression. However, scarce epidemiological data show that albuminuria measurements are only conducted in a minority of individuals and disease recognition is suboptimal, even in high-risk groups. The current study aims to evaluate if and how early identification of chronic kidney disease by targeted screening of albuminuria levels is feasible in primary care (pharmacies and general practitioners) to optimally discover and treat patients with elevated albuminuria.

Interventions

DIAGNOSTIC_TESTAlbuminuria test

During participation, subjects are asked to collect one or more urine samples for albuminuria determination.

DIAGNOSTIC_TESTHbA1c test

During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).

DIAGNOSTIC_TESTCreatinine test

During the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott).

Sponsors

University Medical Center Groningen
CollaboratorOTHER
General Practitioners Research Institute
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Diabetes Mellitus (diagnosis or prescription for the disease based on the NHG guidelines) * Adipositas (diagnosis) * Hypertension (diagnosis or prescription for the disease based on the NHG guidelines) * Cardiovascular disease (diagnosis, specified in protocol section 5.2.2) * Lipid disorder (diagnosis or prescription for the disease based on the NHG guidelines)

Exclusion criteria

* Inability to understand and sign the informed consent form * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of elevated albuminuria1-2 weeks after invitationdefined as a confirmed urinary albumin creatinine ratio (UACR) ≥ 3.0 mg/mmol.

Secondary

MeasureTime frameDescription
The prevalence of unknown elevated albuminuriathrough study completion, an average of 5 weeksdefined as elevated albuminuria not reported by the subject or previously recorded in electronic medical records of the subjects' general practice or pharmacy.
Average costs per subjectthrough study completion, an average of 5 weeksby screening for albuminuria via pharmacies versus general practitioners.
the proportion of invited subjects that was identified as having hidden kidney diseasethrough study completion, an average of 5 weeksby screening for albuminuria via pharmacies versus general practitioners.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026