A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

July 18, 2022 updated by: Astute Medical, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
          • Research Coordinator Manager

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patients with KDIGO stage 2 or 3 AKI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with KDIGO stage 2 or 3 AKI
Diagnostic test: Urine collection for NEPHROCLEAR CCL14 Test
Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication
Time Frame: Within 5 days
Within 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astute Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIAMOND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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