VIDAS® NEPHROCLEAR Reference Interval Study

NCT06037109 | Completed FDA Device

• 1 other identifier: B3166-CTPR03
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• CCL14 concentration in urine

  CCL14 concentration will be measured using the VIDAS Necphroclear CCL14 Assay

  Samples tested within 2 years of collection

Study Arms (2)

Apparently Healthy Adults

Apparently healthy adults (age ≥ 21 years); who have provided written informed consent for sample use in this study

Device: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test

Adults with Chronic, Stable Morbidities

Adults (age ≥ 21 years);with one or more of the following chronic, stable morbid conditions.

Device: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test

Interventions

Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test DEVICE

Previously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test

Adults with Chronic, Stable Morbidities; Apparently Healthy Adults

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples were collected from apparently healthy adults (n = \~300) and adults with pre-specified underlying chronic stable morbidities (n = \~300).

You may qualify if:

• Apparently healthy adults (age ≥ 21 years);
• Provide written informed consent for study (AST-017) participation

You may not qualify if:

• Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
• Any known or suspected significant new onset or chronic morbid medical condition such as:
• Active cancer
• Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia)
• Chronic coagulation abnormality
• Chronic obstructive pulmonary disease (including emphysema, chronic bronchitis, and asthma)
• Chronic pancreatitis
• Chronic renal insufficiency
• Congestive heart failure
• Coronary artery disease
• Diabetes mellitus (Type 1 or Type 2)
• Gout
• Hyper- or hypothyroidism
• Hyperlipidemia (includes hypercholesterolemia)
• Hypertension

Sponsors & Collaborators

• BioMérieux: lead

Study Sites (2)

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: July 18, 2023
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)