Clinical Validation of the RENISCHEM L-FABP POC Assay (SAKURA-POC)

February 23, 2026 updated by: Hikari Dx, Inc.

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will validate the ability of the RENISCHEM L-FABP POC test to predict AKI risk in patients undergoing cardiac catheterization and receiving iodinated contrast medium. Contrast medium is known to be both vasoconstrictive and chemotoxic, which can lead to renal ischemia and, ultimately, AKI. Infusion of radiographic contrast agents, with the associated increases in osmotic load and viscosity, increases hypoxia of the renal medulla and increases renal free radical production through post-ischemic oxidative stress. Earlier identification of contrast medium-induced acute kidney injury (CI-AKI) risk can facilitate improved management of patients to prevent AKI, for example, through selection of alternative imaging methods or contrast agents.

Subjects will be recruited prospectively based on pre-specified enrollment criteria. Blood and urine samples will be collected after enrollment and at several timepoints, and various tests will be performed, including point-of-care L-FABP measurements on urine samples.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
    • California
      • Concord, California, United States, 94520
        • John Muir Health
    • Florida
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Jacksonville, Florida, United States, 32209
        • University of Florida at Jacksonville
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will include patients recruited from a healthcare setting that will be undergoing cardiac or vascular interventional procedures that are at elevated risk for developing AKI. At least 50% of the enrolled population will be undergoing an interventional procedure such as percutaneous coronary intervention (PCI), transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI).

Description

Inclusion 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of acute kidney injury
Time Frame: Within 2 days after a cardiac or vascular catheterization procedure involving the use of contrast media
AKI defined as stage 1, 2, or 3 using the KDIGO criteria
Within 2 days after a cardiac or vascular catheterization procedure involving the use of contrast media

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hikari Dx, Inc.

Collaborators

Timewell Medical Co., Ltd.

Investigators

  • Principal Investigator: Peter McCullough, Independent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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