Clinical Validation of the RENISCHEM L-FABP POC Assay (NCT04864847) | Clinical Trial Compass
CompletedNot Applicable
Clinical Validation of the RENISCHEM L-FABP POC Assay
United States382 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a point-of-care urine test called the RENISCHEM L-FABP assay to detect acute kidney injury early — is this type of test something you currently use or have access to, and could it be relevant for monitoring my kidney health?
2Since this trial focused specifically on contrast-induced nephropathy, if I need imaging or a procedure that uses contrast dye, should we be checking my kidney function beforehand using a test like this one, or is there a standard approach you already follow?
3The trial is now completed — has its data been published yet, and if so, what did the results suggest about how reliably this L-FABP test can spot acute kidney injury compared to traditional blood or urine tests?
4If my kidneys are at risk and a test like this isn't yet available in your practice, what early warning signs or current monitoring methods would you use to catch kidney injury as quickly as possible?
5Given that this was a validation study rather than a treatment trial, how would a more accurate early detection tool for acute kidney injury actually change the treatment decisions you'd make for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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