Screening of Microalbuminuria Using a Semi-quantitative UACR Test

NCT ID: NCT03238547

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Microalbuminuria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

diabetes

Diabetes patients with normal renal function and normal urinalysis

semi-quantitative urine albumin-to-creatinine ratio test

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

standard quantitative spot urine albumin-to-creatinine ratio

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* diabetes

Exclusion Criteria

* microscopic hematuria
* pyuria
* urinary cast
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dong Ki Kim

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

URiSCAN_SNU_01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.