RECRUITING

Clinical Validation of the RENISCHEM L-FABP POC Assay

Description

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

Acute Kidney InjuryContrast-induced Nephropathy
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Related Conditions:

Acute Kidney InjuryContrast-induced Nephropathy

Study Overview

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Study Details

Study overview

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.

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

Clinical Validation of the RENISCHEM L-FABP POC Assay

Condition
Acute Kidney Injury
Intervention / Treatment

-

Contacts and Locations

Chandler

Chandler Regional Medical Center, Chandler, Arizona, United States, 85224

Concord

John Muir Health, Concord, California, United States, 94520

Clearwater

Clearwater Cardiovascular Consultants, Clearwater, Florida, United States, 33756

Jacksonville

University of Florida at Jacksonville, Jacksonville, Florida, United States, 32209

Baltimore

Sinai Hospital of Baltimore, Baltimore, Maryland, United States, 21215

Oklahoma City

University of Oklahoma, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients age 18 or older on the day of the procedure
  • * Undergoing cardiac or vascular interventional procedures for diagnostic angiography, coronary intervention, TAVR or TAVI, with planned use of radiocontrast media within the next 30 days
  • * Able to provide informed consent
  • * Available to participate in follow-up visits
  • * eGFR \< 45 within the last 90 days, or
  • * eGFR \< 60 within the last 90 days with at least one (1) of the following risk factors:
  • * Diabetes
  • * Heart failure (acute or chronic)
  • * Anemia (hemoglobin \< 12 g/dL for females and \< 13 g/dL for males) within the last 90 days
  • * Age \> 75 on the day of the procedure
  • * Patient on dialysis or with eGFR \< 15 within the last 30 days
  • * History of renal transplant
  • * Current use of immunosuppressive drugs other than prednisone \< 10 mg/day
  • * Current clinically significant infection (including HIV, hepatitis)
  • * Presence of KDIGO Stage 1, 2, or 3 AKI within the last 7 days, according to KDIGO criteria
  • * Known or suspected nephritic or nephrotic syndrome.
  • * A current post-renal etiology of renal impairment
  • * Known allergy or hypersensitivity to radiographic contrast dye that cannot be pre-medicated
  • * Females that are known to be pregnant or nursing
  • * Participation within the last 30 days in another clinical trial involving use of any drug known to affect AKI and/or device known to affect AKI

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hikari Dx, Inc.,

Peter McCullough, PRINCIPAL_INVESTIGATOR, Independent

Study Record Dates

2025-12-31