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NCT03238547

Screening of Microalbuminuria Using a Semi-quantitative UACR Test

Completed Last updated 25 March 2020
What this trial tests

trial testing semi-quantitative urine albumin-to-creatinine ratio test in Diabetes in 1,000 participants. Completed in 31 December 2019.

Timeline
1 August 2017
Primary endpoint
31 December 2019
31 December 2019

Quick facts

Lead sponsorSeoul National University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,000
Start date1 August 2017
Primary completion31 December 2019
Estimated completion31 December 2019
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Seoul National University Hospital

Who can join

18 and older, any sex, with Diabetes or Microalbuminuria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Can a semi-quantitative method replace the current quantitative method for the annual screening of microalbuminuria in patients with diabetes? Diagnostic accuracy and cost-saving analysis considering the potential health burden.
    Kim Y, Park S, Kim MH, Song SH, et al · · 2020 · cited 8× · PMID 31961894 · DOI 10.1371/journal.pone.0227694

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Other recruiting trials for Diabetes

Currently open trials in the same condition.

Other Seoul National University Hospital trials

Trials by the same sponsor.

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