Screening of Microalbuminuria Using a Semi-quantitative UACR Test

Completed

• Conditions: Diabetes; Microalbuminuria
• Interventions: Diagnostic Test: semi-quantitative urine albumin-to-creatinine ratio test; Diagnostic Test: standard quantitative spot urine albumin-to-creatinine ratio

• Registration Number: NCT03238547
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Microalbuminuria is an important biomarker for the development of diabetic nephropathy and cardiovascular complications. Since microalbuminuria is not easily detected on routine urinalysis, current guidelines recommend measuring spot urine albumin-to-creatinine ratio (uACR) annually in a patient with diabetes mellitus. While the standard method is quantitative measurement using turbidimetric immunoassay, it requires high cost and special laboratory equipment. This may be a hurdle that prevents screening for microalbuminuria in many patients with diabetes. Therefore, a semi-quantitative uACR test, which is rapid and inexpensive, could be used as a substitute to the current standard quantitative measurement. The investigators aimed to assess the diagnostic accuracy of a semi-quantitative urine albumin-to-creatinine ratio test, URiSCAN 2ACR, as a screening tool for microalbuminuria in patients with diabetes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-29
• Study Start: 2017-08-01
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-03
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• diabetes

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Exclusion Criteria

• microscopic hematuria
• pyuria
• urinary cast

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetes	semi-quantitative urine albumin-to-creatinine ratio test	Diabetes patients with normal renal function and normal urinalysis
diabetes	standard quantitative spot urine albumin-to-creatinine ratio	Diabetes patients with normal renal function and normal urinalysis

Primary Outcome Measures

Name	Time	Method
Diagnostic Sensitivity and Specificity	through study completion, an average of 18 months	Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of