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New urine test could spot kidney danger in ICU patients early

NCT ID NCT06652100

Diagnosis Sponsor: BioPorto Diagnostics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study involves 800 adults in intensive care who provide urine samples to test a new lab test called ProNephro AKI (NGAL). The goal is to find the right cutoff value that best identifies patients at risk for moderate to severe acute kidney injury within 48-72 hours. The test measures a protein in urine that rises when kidneys are stressed. If the cutoff is established, it could help doctors act faster to protect kidney function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ProNephro AKI (NGAL) urine test
What this could lead to
If successful, this could give doctors a reliable urine test to quickly identify ICU patients at high risk for serious kidney injury, allowing earlier intervention.
What could go wrong
This is an observational study to establish a cutoff value, not a treatment trial. The test may not prove accurate enough in all patient groups, and results may not change outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients admitted to the ICU 22 years of age and older

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Male and females ≥ 22 years of age. Subjects must be admitted to an Intensive Care Unit and must have a urine sample collected within 24 hours of ICU admission. Subjects must have at least one of the following leading to admission to the ICU, or occurring within 24 hours of admission to the ICU: * Vasoactive medication administration * Mechanical ventilation * Hypoxemia requiring oxygen support therapy including Bilevel positive airway pressure (BIPAP) and high flow nasal canula * Mean arterial pressure (MAP) less than 60 (within 12 hrs. of ICU admission only) * Serum Lactate greater than 2.5 mmol/L * History of solid organ transplantation, renal transplantation included only if more than 3 months prior * History of bone marrow transplantation Subject with signed informed consent. Exclusion Criteria: Special populations including pregnant and lactating women, prisoners, or institutionalized individuals. Subjects receiving Kidney Replacement Therapy in the first 24 hours of ICU admission. Subjects diagnosed with active Urinary Tract Infection per institute standard of care at the time of NGAL sampling. Subjects with a known history of chronic kidney disease stages 4 and 5 as evidenced by a pre-enrollment estimated GFR of less than 30 mL/min/1.73M2 and under the care of a nephrologist. Subjects with any known urothelial, urological or kidney malignancies. Subjects that have had any urologic procedure or urologic surgery immediately prior to admission to the ICU. Subjects that have had surgical nephrectomy less than 3 months prior to admission. Subjects that have been previously enrolled in this study. Subjects that do not have a baseline sCR within 6 months prior to ICU admission available. Subjects that did not sign the informed consent. Subjects enrolled in an interventional pharmaceutical or device clinical trial at time of ICU admission

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University

    New York, New York, 10032, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • The University of Alabama

    Birmingham, Alabama, 35233, United States

  • UC Davis

    Sacramento, California, 95817, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27109, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.