VIDAS® NEPHROCLEAR Diagnostic Accuracy Study | NCT06036758

Studies
VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

NCT06036758

Sponsor

BioMérieux

Status

Completed

Last Update Posted

Feb 28, 2024Actual

Enrollment

477Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Stage 2 Acute Kidney Injury
Stage 3 Acute Kidney Injury

Interventions

VIDAS® NEPHROCLEAR™ CCL14 Test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2023Actual

Primary Completion Date

Dec 28, 2023Actual

Completion Date

Dec 28, 2023Actual

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

477Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VIDAS® NEPHROCLEAR™ CCL14 Test	Diagnostic Test	Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test	Persons with Stage 2 to Stage 3 AKI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Persons with Stage 2 to Stage 3 AKI

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
George Washington University		Washington D.C.	District of Columbia	20052	United States
University of Illinois

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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