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Clinical Validation of the RENISCHEM L-FABP POC Assay

NCT04864847 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2026-02-25

No results posted yet for this 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.

Conditions

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.

Sponsors & Collaborators

  • Timewell Medical Co., Ltd.

    collaborator UNKNOWN

  • Hikari Dx, Inc.

    lead OTHER

Principal Investigators

  • Peter McCullough · Independent

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04864847 on ClinicalTrials.gov