Clinical Validation of the RENISCHEM L-FABP POC Assay

NCT04864847 | Active Not Recruiting FDA Device

• 1 other identifier: TWM-001
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 6

Brief 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

Contrast-induced Nephropathy; Acute Kidney Injury

Keywords

L-FABP; Point of Care

Outcome Measures

Primary Outcomes (1)

• Development of acute kidney injury

  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

Interventions

RENISCHEM L-FABP POC Test DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hikari Dx, Inc.: lead
• Timewell Medical Co., Ltd.: collaborator

Study Sites (6)

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

John Muir Health

Concord, California, 94520, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

University of Florida at Jacksonville

Jacksonville, Florida, 32209, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (6)

• Noiri E, Doi K, Negishi K, Tanaka T, Hamasaki Y, Fujita T, Portilla D, Sugaya T. Urinary fatty acid-binding protein 1: an early predictive biomarker of kidney injury. Am J Physiol Renal Physiol. 2009 Apr;296(4):F669-79. doi: 10.1152/ajprenal.90513.2008. Epub 2008 Nov 19.

  PMID: 19019918 BACKGROUND

• Yamamoto T, Noiri E, Ono Y, Doi K, Negishi K, Kamijo A, Kimura K, Fujita T, Kinukawa T, Taniguchi H, Nakamura K, Goto M, Shinozaki N, Ohshima S, Sugaya T. Renal L-type fatty acid--binding protein in acute ischemic injury. J Am Soc Nephrol. 2007 Nov;18(11):2894-902. doi: 10.1681/ASN.2007010097. Epub 2007 Oct 17.

  PMID: 17942962 BACKGROUND

• Fujita D, Takahashi M, Doi K, Abe M, Tazaki J, Kiyosue A, Myojo M, Ando J, Fujita H, Noiri E, Sugaya T, Hirata Y, Komuro I. Response of urinary liver-type fatty acid-binding protein to contrast media administration has a potential to predict one-year renal outcome in patients with ischemic heart disease. Heart Vessels. 2015 May;30(3):296-303. doi: 10.1007/s00380-014-0484-9. Epub 2014 Feb 20.

  PMID: 24554034 BACKGROUND

• Kamijo-Ikemori A, Hashimoto N, Sugaya T, Matsui K, Hisamichi M, Shibagaki Y, Miyake F, Kimura K. Elevation of urinary liver-type fatty acid binding protein after cardiac catheterization related to cardiovascular events. Int J Nephrol Renovasc Dis. 2015 Aug 18;8:91-9. doi: 10.2147/IJNRD.S88467. eCollection 2015.

  PMID: 26316797 BACKGROUND

• Manabe K, Kamihata H, Motohiro M, Senoo T, Yoshida S, Iwasaka T. Urinary liver-type fatty acid-binding protein level as a predictive biomarker of contrast-induced acute kidney injury. Eur J Clin Invest. 2012 May;42(5):557-63. doi: 10.1111/j.1365-2362.2011.02620.x. Epub 2011 Nov 10.

  PMID: 22070248 BACKGROUND

• Nakamura T, Sugaya T, Node K, Ueda Y, Koide H. Urinary excretion of liver-type fatty acid-binding protein in contrast medium-induced nephropathy. Am J Kidney Dis. 2006 Mar;47(3):439-44. doi: 10.1053/j.ajkd.2005.11.006.

  PMID: 16490622 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine specimens

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter McCullough

  Independent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: October 1, 2021
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)