VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study

This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Stage 2 Acute Kidney Injury; Stage 3 Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: VIDAS® NEPHROCLEAR™ CCL14 Test

Detailed Description

The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment.

The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or older.

The objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values.

Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results.

• Study Type: Observational
• Enrollment (Actual): 477

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20052
      • George Washington University
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons with Stage 2 to Stage 3 AKI

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Prior kidney transplantation;
• Comfort-measures-only status;
• Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
• Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
• Special populations, pregnant women, prisoners or institutionalized individuals;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Persons with Stage 2 to Stage 3 AKI; Persons with Stage 2 to Stage 3 AKI who are in the ICU.	Diagnostic test: VIDAS® NEPHROCLEAR™ CCL14 Test; Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of developing persistent severe AKI	The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment	Within 48 hours of ICU admittance

Collaborators and Investigators

• Sponsor: BioMérieux

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: B3166-CTPR02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No