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

Completed

• Conditions: Albuminuria; Chronic Kidney Diseases
• Interventions: Diagnostic Test: Albuminuria test; Diagnostic Test: HbA1c test; Diagnostic Test: Creatinine test

• Registration Number: NCT05321095
• Lead Sponsor: General Practitioners Research Institute

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.

Study Timeline

• Study Start: 2021-11-25
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-04-01
• Study First Posted: 2022-04-11
• Primary Completion: 2023-12-31
• Status Verified: 2024-02
• Study Completion: 2024-07-30
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening	HbA1c test	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.
Screening	Albuminuria test	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.
Screening	Creatinine test	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average costs per subject	through study completion, an average of 5 weeks	by screening for albuminuria via pharmacies versus general practitioners.
The prevalence of unknown elevated albuminuria	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.
the proportion of invited subjects that was identified as having hidden kidney disease	through study completion, an average of 5 weeks	by screening for albuminuria via pharmacies versus general practitioners.

Trial Locations

Locations (1)

General Practitioners Research Institute; 🇳🇱 Groningen, Netherlands