Clinical Validation of the RENISCHEM L-FABP POC Assay

Acute Kidney Injury Clinical Trial

— SAKURA-POC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864847
• Other study ID #: TWM-001
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: October 2023
• Source: Hikari Dx, Inc.
• Contact: Jeffrey Dahlen, Ph.D.
• Phone: (619) 742-0203
• Email: jeff[@]hikaridx.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast-induced Nephropathy

Intervention

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.

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	John Muir Health	Concord	California
United States	University of Florida at Jacksonville	Jacksonville	Florida
United States	University of Oklahoma	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Hikari Dx, Inc.	Timewell Medical Co., Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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