Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING

Clinical Validation of the RENISCHEM L-FABP POC Assay

NCT04864847 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DIAGNOSTIC_TEST RENISCHEM L-FABP POC Test

Study Locations (6)

Florida

  • Clearwater Cardiovascular Consultants — Clearwater
  • University of Florida at Jacksonville — Jacksonville

Arizona

  • Chandler Regional Medical Center — Chandler

California

  • John Muir Health — Concord

Maryland

  • Sinai Hospital of Baltimore — Baltimore

Oklahoma

  • University of Oklahoma — Oklahoma City

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2021-10-01
Est. Completion 2026-02

Sponsor

Hikari Dx

2 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04864847

The ClinicalTrials.gov registry entry for NCT04864847 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hikari Dx, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention — of which RENISCHEM L-FABP POC Test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04864847 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04864847 about?

NCT04864847 is a clinical study titled "Clinical Validation of the RENISCHEM L-FABP POC Assay". 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 follow...

What is the current status of trial NCT04864847?

This trial is currently active not recruiting. The enrollment target is 450 participants. The study started on 2021-10-01. Estimated completion is 2026-02.

What conditions does trial NCT04864847 study?

This clinical trial studies the following conditions: Acute Kidney Injury, Contrast-induced Nephropathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04864847?

The interventions under investigation include: RENISCHEM L-FABP POC Test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04864847?

This trial is sponsored by Hikari Dx, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04864847 being conducted?

This trial has 6 study locations across Arizona, California, Florida, Maryland, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial