Clinical Validation of the RENISCHEM L-FABP POC Assay

Launched by HIKARI DX, INC. · Apr 26, 2021

Keywords

ClinConnect Summary

This clinical trial, called the RENISCHEM L-FABP POC Assay, is studying a new test that measures a substance in urine called L-FABP. This test aims to help predict if patients will develop a condition called Acute Kidney Injury (AKI) within two days after certain heart or blood vessel procedures that use a special dye known as radiocontrast media. By using this new test, doctors hope to improve how they can identify patients at risk for kidney problems early on.

To participate in the trial, patients need to be at least 18 years old and scheduled for specific heart or blood vessel procedures that will use radiocontrast media. They should have certain risk factors for kidney issues, such as a lower kidney function (measured by something called eGFR), diabetes, or being over 75 years old. Participants will provide urine samples and may need to attend follow-up visits to help researchers gather information about the test's effectiveness. It’s important for potential participants to know that there are specific criteria that could exclude them, such as having a history of kidney transplant or currently being on dialysis. Overall, this trial aims to better understand how this new test can help protect patients’ kidney health during important medical procedures.

Gender

ALL

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