NCT04864847

Clinical Validation of the RENISCHEM L-FABP POC Assay

A Study of Contrast-induced Acute Kidney Injury Prediction Using the RENISCHEM L-FABP Assay at the Point-of-Care

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Hikari Dx, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will validate the ability of the RENISCHEM L-FABP POC test to predict AKI risk in patients undergoing cardiac catheterization and receiving iodinated contrast medium. Contrast medium is known to be both vasoconstrictive and chemotoxic, which can lead to renal ischemia and, ultimately, AKI. Infusion of radiographic contrast agents, with the associated increases in osmotic load and viscosity, increases hypoxia of the renal medulla and increases renal free radical production through post-ischemic oxidative stress. Earlier identification of contrast medium-induced acute kidney injury (CI-AKI) risk can facilitate improved management of patients to prevent AKI, for example, through selection of alternative imaging methods or contrast agents. Subjects will be recruited prospectively based on pre-specified enrollment criteria. Blood and urine samples will be collected after enrollment and at several timepoints, and various tests will be performed, including point-of-care L-FABP measurements on urine samples.

Conditions

• Acute Kidney Injury
• Contrast-induced Nephropathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	RENISCHEM L-FABP POC Test	Point-of-care test cassette with quantitative reader used for the measurement of L-type fatty acid binding protein (L-FABP) in human urine specimens.

Timeline

• Start date: 2021-10-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2021-04-29
• Last updated: 2026-02-25

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study