A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

Acute Kidney Injury Clinical Trial

Official title:

A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785391
• Other study ID #: Diamond
• Status: Recruiting
• Start date: June 8, 2021
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Astute Medical, Inc.
• Contact: Clinical Trials Manager
• Phone: 858-500-7000
• Email: astuteclinical[@]biomerieux.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Diagnostic Test:
• Urine collection for NEPHROCLEAR CCL14 Test
Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Astute Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication		Within 5 days