Clinical trial NCT04864847: Clinical Validation of the RENISCHEM L-FABP POC Assay
Official title: A Study of Contrast-induced Acute Kidney Injury Prediction Using the RENISCHEM L-FABP Assay At the Point-of-Care
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Contrast-induced Nephropathy
Keywords: L-FABP
Point of Care
Lead sponsor: Hikari Dx, Inc.
Sponsor class: OTHER
Collaborators: name: Timewell Medical Co., Ltd.
First posted: 2021-04-29
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of acute kidney injury
timeFrame: Within 2 days after a cardiac or vascular catheterization procedure involving the use of contrast media
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Concord
country: United States
facility: John Muir Health
state: California
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Jacksonville
country: United States
facility: University of Florida at Jacksonville
state: Florida
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
affiliation: Independent
name: Peter McCullough
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.