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

Study Overview
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Brief Summary
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Early detection of kidney disease

Detailed Description
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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.

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

Conditions
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Chronic Kidney Diseases, Albuminuria

Intervention / Treatment
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* Diagnostic Test: Albuminuria test
* Diagnostic Test: HbA1c test
* Diagnostic Test: Creatinine test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Screening<br>Only one group will be evaluated during the SALINE study. Everyone that meets the inclusion criteria of having a high risk for albuminuria is invited to participate. During participation, subjects are asked to collect one or more urine samples for albuminuria determination. If albuminuria is high (>= 3,0 mg/mmol) subjects are invited for a visit. During the visit non-invasive measurements (BMI, PoC HbA1c, eGFR, blood pressure and heart rate) are taken to determine the cardiovascular risk. Furthermore, medication use is reviewed. | Diagnostic Test: Albuminuria test<br>* During participation, subjects are asked to collect one or more urine samples for albuminuria determination.<br>* Other names: PeeSpot;Diagnostic Test: HbA1c test<br>* During the screening visit, HbA1c will be measured with a point-of-care test (Affinion HbA1c, Abbott).<br>* Other names: Affinion HbA1c;Diagnostic Test: Creatinine test<br>* During the screening visit, creatinine will be measured with a point-of-care test (i-STAT Alinity handheld analyser, Abbott).<br>* Other names: i-STAT Alinity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of elevated albuminuria | defined as a confirmed urinary albumin creatinine ratio (UACR) ≥ 3.0 mg/mmol. | 1-2 weeks after invitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of unknown elevated albuminuria | defined as elevated albuminuria not reported by the subject or previously recorded in electronic medical records of the subjects' general practice or pharmacy. | through study completion, an average of 5 weeks | 
| Average costs per subject | by screening for albuminuria via pharmacies versus general practitioners. | through study completion, an average of 5 weeks | 
| the proportion of invited subjects that was identified as having hidden kidney disease | by screening for albuminuria via pharmacies versus general practitioners. | through study completion, an average of 5 weeks |