Status:
COMPLETED
VIDAS® NEPHROCLEAR Reference Interval Study
Lead Sponsor:
BioMérieux
Conditions:
Healthy
Eligibility:
All Genders
21+ years
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 t...
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 ri...
Eligibility Criteria
Inclusion
- Cohort A
- Apparently healthy adults (age ≥ 21 years);
- Provide written informed consent for study (AST-017) participation
Exclusion
- 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.
Key Trial Info
Start Date :
July 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 28 2023
Estimated Enrollment :
585 Patients enrolled
Trial Details
Trial ID
NCT06037109
Start Date
July 18 2023
End Date
December 28 2023
Last Update
February 28 2024
Active Locations (2)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20052
2
University of Illinois Chicago
Chicago, Illinois, United States, 60612