A Sample Collection Study to Validate the NEPHROCLEAR™ CC... | NCT04785391

Studies
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

NCT04785391

Sponsor

Astute Medical, Inc.

Status

Unknown status

Last Update Posted

Jul 20, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Urine collection for 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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2021Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Mar 1, 2021

First Submission Date that Met QC Criteria

Mar 4, 2021

First Posted Date

Mar 5, 2021Actual

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

Jul 18, 2022

Last Update Posted Date

Jul 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

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

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with KDIGO stage 2 or 3 AKI			Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Urine collection for NEPHROCLEAR CCL14 Test	Diagnostic Test	Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test	Patients with KDIGO stage 2 or 3 AKI

Outcomes Module

Primary Outcomes

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

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;
Written 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);
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

Adult ICU patients with KDIGO stage 2 or 3 AKI.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Manager	Contact	858-500-7000		astuteclinical@biomerieux.com

Overall Officials

Name	Affiliation	Role
Jay L Koyner, MD	University of Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center	Recruiting	Pittsburgh	Pennsylvania	15261	United States

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

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059349	Urine Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided