A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

• Conditions: Acute Kidney Injury
• Interventions: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

• Registration Number: NCT04785391
• Lead Sponsor: Astute Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-04
• Study First Posted: 2021-03-05
• Study Start: 2021-06-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with KDIGO stage 2 or 3 AKI	Urine collection for NEPHROCLEAR CCL14 Test	-

Primary Outcome Measures

Name	Time	Method
Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication	Within 5 days

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States