Acute Kidney InjuryNCT06036758
VIDAS® NEPHROCLEAR Diagnostic Accuracy Study
An observational study of Acute Kidney Injury and Stage 2 Acute Kidney Injury, 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 persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate the VIDAS® NEPHROCLEAR™ CCL14 Test Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Kidney Injury, Stage 2 Acute Kidney Injury, Stage 3 Acute Kidney Injury
- What is being tested?
- VIDAS® NEPHROCLEAR™ CCL14 Test
- How many people
- 477 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 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
- No healthy volunteers
- Adult, Older adult
Study population: Persons with Stage 2 to Stage 3 AKI
Who may be able to join
- Males and females 21 years of age or older;
- Receiving care in an intensive care unit;
- Expected to remain in the ICU for at least 48 hours after enrollment;
- Use of indwelling urinary catheter as standard care at the time of enrollment;
- Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
- Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
- Documented informed consent provided by patient or legally authorized representative (LAR).
Who cannot join
- Prior kidney transplantation;
- Comfort-measures-only status;
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
- Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
- Special populations, pregnant women, prisoners or institutionalized individuals;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Illinois
Chicago, Illinois, 60612
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study
This is a multi-center sample analysis study in which urine samples previously collected from persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate 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 evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values.
Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results.
- Being tested
- VIDAS® NEPHROCLEAR™ CCL14 Test
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIDAS® NEPHROCLEAR™ CCL14 TestDiagnostic test
Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test
| Study group | Role | What they receive |
|---|---|---|
| Persons with Stage 2 to Stage 3 AKI | Persons with Stage 2 to Stage 3 AKI who are in the ICU. Receives: Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of developing persistent severe AKI
The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which 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
Measured: Within 48 hours of ICU admittance
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 start17 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 Acute Kidney InjuryStudies 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
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036758
- Sponsor's protocol ID
- B3166-CTPR02
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 28 Feb 2024
- Results posted
- 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 Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT06036758
- Acronym / sponsor ID
- B3166-CTPR02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 17 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 persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to validate 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 evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™ CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative risk (RR), will be evaluated at the pre-determined cut-off values.
Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in this study. The VIDAS® test results will be compared to the clinical AKI status established by independent adjudication by medical professionals, that are blinded to the VIDAS® test results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with Stage 2 to Stage 3 AKI | – | Diagnostic Test: VIDAS® NEPHROCLEAR™ CCL14 TestPersons with Stage 2 to Stage 3 AKI who are in the ICU. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with Stage 2 to Stage 3 AKI
Key inclusion criteria (7 listed)
- Males and females 21 years of age or older;
- Receiving care in an intensive care unit;
- Expected to remain in the ICU for at least 48 hours after enrollment;
- Use of indwelling urinary catheter as standard care at the time of enrollment;
- Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
Key exclusion criteria (5 listed)
- Prior kidney transplantation;
- Comfort-measures-only status;
- Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
- Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.)
- Special populations, pregnant women, prisoners or institutionalized individuals;
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 |
|---|---|---|
| VIDAS® NEPHROCLEAR™ CCL14 TestUrine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test | Diagnostic test | Persons with Stage 2 to Stage 3 AKI |
Primary outcome
Risk of developing persistent severe AKI
Time frame: Within 48 hours of ICU admittance
The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which 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
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 Acute Kidney Injury and Stage 2 Acute Kidney Injury, 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 7 inclusion and 5 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?
Risk of developing persistent severe AKI (time frame: Within 48 hours of ICU admittance). 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; AzTrials last refreshed its copy on 29 Oct 2026.