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OpenTrials
Completed

NCT Number: NCT03238547

Screening of Microalbuminuria Using a Semi-quantitative UACR Test

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Microalbuminuria Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes

Exclusion criteria

  • microscopic hematuria
  • pyuria
  • urinary cast

Treatment and study plan

semi-quantitative urine albumin-to-creatinine ratio test

Diagnostic Test

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

standard quantitative spot urine albumin-to-creatinine ratio

Diagnostic Test

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2017
Registry last updated
Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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