Urine Sample Processing Study

• Sponsor: Astute Medical, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05483088
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 10.6
• Patients Per Site Per Month: 11.3

Study Details

Study Description

Brief Summary

The objective of the study is to collect and process urine samples from Intensive Care Unit (ICU) subjects with moderate to severe (Stage 2 or 3) acute kidney injury (AKI) for use in assessing the effects of urine sample freezing and various storage conditions on NEPHROCLEAR™ CCL14 Test results. This study is observational and will have no impact on the medical management of the subject.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Urine Sample Processing Study: Analysis of Fresh Versus Frozen Urine Samples From ICU Subjects
• Actual Study Start Date: Nov 12, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with KDIGO stage 2 or 3 AKI	Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test; Urine will be collected for analysis with the NEPHROCLEAR CCL14 Test

Outcome Measures

Primary Outcome Measures

1. Stability of CCL14 in urine samples [Up to 24 hours]

   Stability of CCL14 in urine samples as measured by the NEPHROCLEAR™ CCL14 Test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland, Baltimore	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• Astute Medical, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Astute Medical, Inc.
• ClinicalTrials.gov Identifier: NCT05483088
• Other Study ID Numbers: Turquoise
• First Posted: Aug 1, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Acute Kidney Injury

Study Results

No Results Posted as of Aug 1, 2022