HealthyNCT06037109
VIDAS® NEPHROCLEAR Reference Interval Study
An observational study of Healthy, run by BioMérieux at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test
- Type of treatment
- Medical device
- How many people
- 585 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2023to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Samples were collected from apparently healthy adults (n = ~300) and adults with pre-specified underlying chronic stable morbidities (n = ~300).
Who may be able to join
- Apparently healthy adults (age ≥ 21 years);
- Provide written informed consent for study (AST-017) participation
- Adults (age ≥ 21 years);
- One or more of the following chronic, stable morbid conditions:
- Active cancer
- Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia)
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- 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.
Who cannot join
- 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)
Show all 38Show fewer
- 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
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois Chicago
Chicago, Illinois, 60612
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: 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.
Read the 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
- Being tested
- Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 TestDevice
Previously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test
| Study group | Role | What they receive |
|---|---|---|
| Apparently Healthy Adults | Apparently healthy adults (age ≥ 21 years); who have provided written informed consent for sample use in this study Receives: 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. Receives: Device: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCL14 concentration in urine
CCL14 concentration will be measured using the VIDAS Necphroclear CCL14 Assay
Measured: Samples tested within 2 years of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start18 Jul 2023
- Primary completion28 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037109
- Sponsor's protocol ID
- B3166-CTPR03
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIDAS® NEPHROCLEAR CCL14 Reference Interval Study
- ClinicalTrials.gov ID
- NCT06037109
- Acronym / sponsor ID
- B3166-CTPR03
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apparently Healthy Adults | – | Device: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 TestApparently healthy adults (age ≥ 21 years); who have provided written informed consent for sample use in this study |
| Adults with Chronic, Stable Morbidities | – | Device: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 TestAdults (age ≥ 21 years);with one or more of the following chronic, stable morbid conditions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Samples were collected from apparently healthy adults (n = ~300) and adults with pre-specified underlying chronic stable morbidities (n = ~300).
Key inclusion criteria (30 listed)
- Apparently healthy adults (age ≥ 21 years);
- Provide written informed consent for study (AST-017) participation
- Adults (age ≥ 21 years);
- One or more of the following chronic, stable morbid conditions:
- Active cancer
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 TestPreviously collected urine samples will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test | Device | Adults with Chronic, Stable Morbidities, Apparently Healthy Adults |
Primary outcome
CCL14 concentration in urine
Time frame: Samples tested within 2 years of collection
CCL14 concentration will be measured using the VIDAS Necphroclear CCL14 Assay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by BioMérieux at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCL14 concentration in urine (time frame: Samples tested within 2 years of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.