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

Hikari Dx

Status: Enrolling

Conditions: Acute Kidney Injury; Contrast-induced Nephropathy

Treatments: Diagnostic Test: RENISCHEM L-FABP POC Test

Study type: Observational

Funder types: Other

Identifiers

NCT04864847

TWM-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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