Screening of Microalbuminuria Using a Semi-quantitative UACR Test

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238547
• Other study ID #: URiSCAN_SNU_01
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diabetes

Exclusion Criteria:

• microscopic hematuria

• pyuria

• urinary cast

Related Conditions & MeSH terms

• Albuminuria
• Diabetes
• Microalbuminuria

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Sensitivity and Specificity	Diagnostic Sensitivity and Specificity of URiSCAN 2ACR compared with standard method	through study completion, an average of 18 months