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Screening of Microalbuminuria Using a Semi-quantitative UACR Test

NCT03238547 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2020-03-25

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

semi-quantitative urine albumin-to-creatinine ratio test

measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test

DIAGNOSTIC_TEST

standard quantitative spot urine albumin-to-creatinine ratio

measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238547 on ClinicalTrials.gov