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Completed No phase listed Observational

Clinical Validation of the RENISCHEM L-FABP POC Assay

ClinicalTrials.gov ID: NCT04864847

Public ClinicalTrials.gov record NCT04864847. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 13, 2026, 9:03 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04864847
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Hikari Dx, Inc.
Other
Enrollment
382 participants

Conditions and interventions

Interventions

Diagnostic Test

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2021
Primary completion
Feb 4, 2026
Completion
Feb 4, 2026
Last update posted
Jun 9, 2026

2021 – 2026

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Chandler Regional Medical Center Chandler Arizona 85224
John Muir Health Concord California 94520
Clearwater Cardiovascular Consultants Clearwater Florida 33756
University of Florida at Jacksonville Jacksonville Florida 32209
Sinai Hospital of Baltimore Baltimore Maryland 21215
University of Oklahoma Oklahoma City Oklahoma 73104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04864847, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 9, 2026 · Synced Sep 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04864847 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →