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OpenTrials
Completed

NCT Number: NCT05321095

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

Early detection of kidney disease

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Albuminuria test

Diagnostic Test

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

Other names: PeeSpot

HbA1c test

Diagnostic Test

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

Other names: Affinion HbA1c

Creatinine test

Diagnostic Test

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

Other names: i-STAT Alinity

Primary outcomes

  1. The prevalence of elevated albuminuria

    Time frame: 1-2 weeks after invitation

    defined as a confirmed urinary albumin creatinine ratio (UACR) ≥ 3.0 mg/mmol.

Secondary outcomes

  1. The prevalence of unknown elevated albuminuria

    Time frame: through study completion, an average of 5 weeks

    defined as elevated albuminuria not reported by the subject or previously recorded in electronic medical records of the subjects' general practice or pharmacy.

  2. Average costs per subject

    Time frame: through study completion, an average of 5 weeks

    by screening for albuminuria via pharmacies versus general practitioners.

  3. the proportion of invited subjects that was identified as having hidden kidney disease

    Time frame: through study completion, an average of 5 weeks

    by screening for albuminuria via pharmacies versus general practitioners.

Sponsors and collaborators

Lead sponsor

General Practitioners Research Institute

Network

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

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

Acronym: SALINE

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 11, 2022
Registry last updated
Aug 9, 2024

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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