VIDAS® NEPHROCLEAR Reference Interval Study

Healthy Clinical Trial

Official title:

VIDAS® NEPHROCLEAR CCL14 Reference Interval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06037109
• Other study ID #: B3166-CTPR03
• Status: Completed
• Start date: July 18, 2023
• Est. completion date: December 28, 2023

Study information

• Verified date: September 2023
• Source: BioMérieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 585
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test
Previously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test

Locations

Country	Name	City	State
United States	University of Illinois Chicago	Chicago	Illinois
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
BioMérieux

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CCL14 concentration in urine	CCL14 concentration will be measured using the VIDAS Necphroclear CCL14 Assay	Samples tested within 2 years of collection