NCT06037109

VIDAS® NEPHROCLEAR Reference Interval Study

VIDAS® NEPHROCLEAR CCL14 Reference Interval Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 585 (actual)
• Sponsor: BioMérieux · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center sample analysis study in which urine samples previously collected from apparently healthy adult subjects, and subjects with stable chronic morbidities but without AKI in order to establish the reference range for 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 determine the reference range for CCL14 concentration in Apparently Healthy Adults and Adults with Chronic, Stable Morbidities

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test	Previously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test

Timeline

• Start date: 2023-07-18
• Primary completion: 2023-12-28
• Completion: 2023-12-28
• First posted: 2023-09-14
• Last updated: 2024-02-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study