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ACTIVE NOT RECRUITING
NCT04864847

Clinical Validation of the RENISCHEM L-FABP POC Assay

Sponsor: Hikari Dx, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

450

Start Date

2021-10-01

Completion Date

2026-02

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

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.

Locations (6)

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