Status:
RECRUITING
Clinical Validation of the RENISCHEM L-FABP POC Assay
Lead Sponsor:
Hikari Dx, Inc.
Collaborating Sponsors:
Timewell Medical Co., Ltd.
Conditions:
Acute Kidney Injury
Contrast-induced Nephropathy
Eligibility:
All Genders
18+ years
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...
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 kno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04864847
Start Date
October 1 2021
End Date
December 31 2025
Last Update
July 28 2025
Active Locations (6)
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1
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
2
John Muir Health
Concord, California, United States, 94520
3
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States, 33756
4
University of Florida at Jacksonville
Jacksonville, Florida, United States, 32209