A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

Astute Medical, Inc.1 site in 1 country500 target enrollmentJune 8, 2021

ConditionsAcute Kidney Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Kidney Injury
Sponsor: Astute Medical, Inc.
Enrollment: 500
Locations: 1
Primary Endpoint: Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject.

Registry

clinicaltrials.gov

Start Date

June 8, 2021

End Date

December 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Astute Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and females 21 years of age or older;
•Receiving care in an intensive care unit;
•Expected to remain in the ICU for at least 48 hours after enrollment;
•Use of indwelling urinary catheter as standard care at the time of enrollment;
•Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
•Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
•Written informed consent provided by patient or legally authorized representative (LAR).

Exclusion Criteria

•Prior kidney transplantation;
•Comfort-measures-only status;
•Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
•Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
•Special populations, pregnant women, prisoners or institutionalized individuals.