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New urine test may spot kidney danger before it strikes

NCT ID NCT04864847

Diagnosis Sponsor: Hikari Dx, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new urine test (RENISCHEM L-FABP) to see if it can predict acute kidney injury within 2 days after heart or blood vessel procedures that use contrast dye. Researchers measured a kidney stress marker in 382 adults at higher risk. The goal was to validate the test's ability to catch kidney damage early.

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

382 people

The number who actually took part.

Started

Oct 2021

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

The study population will include patients recruited from a healthcare setting that will be undergoing cardiac or vascular interventional procedures that are at elevated risk for developing AKI. At least 50% of the enrolled population will be undergoing an interventional procedure such as percutaneous coronary intervention (PCI), transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI).

Ages

18 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: * Patients age 18 or older on the day of the procedure * Undergoing cardiac or vascular interventional procedures for diagnostic angiography, coronary intervention, TAVR or TAVI, with planned use of radiocontrast media within the next 30 days * Able to provide informed consent * Available to participate in follow-up visits * eGFR \< 45 within the last 90 days, or * eGFR \< 60 within the last 90 days with at least one (1) of the following risk factors: * Diabetes * Heart failure (acute or chronic) * Anemia (hemoglobin \< 12 g/dL for females and \< 13 g/dL for males) within the last 90 days * Age \> 75 on the day of the procedure Exclusion Criteria: * Patient on dialysis or with eGFR \< 15 within the last 30 days * History of renal transplant * Current use of immunosuppressive drugs other than prednisone \< 10 mg/day * Current clinically significant infection (including HIV, hepatitis) * Presence of KDIGO Stage 1, 2, or 3 AKI within the last 7 days, according to KDIGO criteria * Known or suspected nephritic or nephrotic syndrome. * A current post-renal etiology of renal impairment * Known allergy or hypersensitivity to radiographic contrast dye that cannot be pre-medicated * Females that are known to be pregnant or nursing * Participation within the last 30 days in another clinical trial involving use of any drug known to affect AKI and/or device known to affect AKI

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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 Contrast-induced nephropathy

Contacts and locations

Locations

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224, United States

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756, United States

  • John Muir Health

    Concord, California, 94520, United States

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215, United States

  • University of Florida at Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

More trials for these conditions

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