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Clinical Trials/NCT03238547
NCT03238547
Completed
Not Applicable

Accuracy of a Semi-quantitative Urine Albumin-to-creatinine Ratio Test as a Screening Tool for Microalbuminuria in Patients With Diabetes

Seoul National University Hospital1 site in 1 country1,000 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Seoul National University Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Diagnostic Sensitivity and Specificity
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dong Ki Kim

Prof.

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • microscopic hematuria
  • urinary cast

Outcomes

Primary Outcomes

Diagnostic Sensitivity and Specificity

Time Frame: through study completion, an average of 18 months

Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method

Study Sites (1)

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