Clinical Validation of the RENISCHEM L-FABP POC Assay

Completed

Conditions studied: Acute Kidney Injury, Contrast-induced Nephropathy

In brief

This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days following cardiac and vascular catheterization procedures involving exposure to radiocontrast media.

Key facts

Study ID

NCT04864847

Run by

Hikari Dx, Inc.

People needed

382

Starts

2021-10-01

Expected to finish

2026-02-05

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chandler Regional Medical Center — Chandler, Arizona, United States
• John Muir Health — Concord, California, United States
• Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
• University of Florida at Jacksonville — Jacksonville, Florida, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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