Clinical Validation of the RENISCHEM L-FABP POC Assay (NCT04864847) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Validation of the RENISCHEM L-FABP POC Assay
United States450 participantsStarted 2021-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Development of acute kidney injury
Timeframe: Within 2 days after a cardiac or vascular catheterization procedure involving the use of contrast media