A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

Astute Medical

Status: Enrolling

Conditions: Acute Kidney Injury

Treatments: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04785391

Diamond

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

500 participants in 1 patient group

Patients with KDIGO stage 2 or 3 AKI

Treatment:

Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test