VIDAS® NEPHROCLEAR Reference Interval Study

VIDAS® NEPHROCLEAR CCL14 Reference Interval Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: 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 determine the reference range for CCL14 concentration in Apparently Healthy Adults and Adults with Chronic, Stable Morbidities

• Study Type: Observational
• Enrollment (Actual): 585

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 Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

Cohort A

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Immunocompromised
• Inflammatory bowel disease (including Crohn's disease and ulcerative colitis)
• Liver cirrhosis
• Neuromuscular disease
• Peripheral vascular disease (a.k.a. peripheral artery disease)
• Polycystic kidney disease
• Rheumatoid arthritis
• Systemic Lupus Erythematosus
• Trauma-related surgery within the last 6 months;
• Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
• Received any blood product transfusion within the previous 2 months;
• Pregnant women or children;
• Prisoners or institutionalized individuals;
• Already provided a urine sample for the AST-017 study

Cohort B

Inclusion Criteria:

• Adults (age ≥ 21 years);
• One or more of the following chronic, stable morbid conditions:
• 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
• Immunocompromised
• Inflammatory bowel disease (including Crohn's disease and ulcerative colitis)
• Liver cirrhosis
• Neuromuscular disease
• Peripheral vascular disease (a.k.a. peripheral artery disease)
• Polycystic kidney disease
• Rheumatoid arthritis
• Systemic Lupus Erythematosus
• Provide written informed consent for study participation.
• For Cohort B subjects in the AST-017 Study:
• Subjects were considered to have the above condition(s) if he/she had the diagnosis by a healthcare professional and/or was under treatment by a healthcare professional for the listed condition(s).
• Subjects with a condition (e.g., hypertension, hypercholesterolemia) controlled by medications were enrolled.
• To be considered chronic and stable, the condition(s) must have been present for at least 1 year and without any acute change (decompensation or improvement) within the 3 months prior to enrollment.

Exclusion Criteria:

• Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
• Any new onset or unstable morbidities;
• Trauma-related surgery within the last 6 months;
• Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
• Received any blood product transfusion within the previous 2 months;
• Pregnant women or children;
• Prisoners or institutionalized individuals;
• Already provided a urine sample for this (AST-017) study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Previously collected urine samples will be tested using the 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; Previously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CCL14 concentration in urine	CCL14 concentration will be measured using the VIDAS Necphroclear CCL14 Assay	Samples tested within 2 years of collection

Collaborators and Investigators

• Sponsor: BioMérieux

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 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

• Other Study ID Numbers: B3166-CTPR03

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