CompletedNot Applicable

VIDAS® NEPHROCLEAR Diagnostic Accuracy Study

United States477 participantsStarted 2023-07-17

Plain-language 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

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). Exclusion Criteria: * 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Risk of developing persistent severe AKI

Timeframe: Within 48 hours of ICU admittance

Trial details

NCT IDNCT06036758

SponsorBioMérieux

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-28

View on ClinicalTrials.gov More Acute Kidney Injury trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.