Fluorescent Probe for Increased Kidney Clearance
(FLARE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called the transdermal glomerular filtration (tGFR) monitor, which allows doctors to measure kidney function more accurately and in real-time. Current methods, such as urine collection or blood tests, can be inconvenient or unreliable, especially for sick patients. The trial compares this new device with traditional methods in hospitalized patients. It seeks critically or acutely ill patients in the intensive care unit with normal kidney function to participate. As a Phase 4 trial, the tGFR monitor has already received FDA approval and proven effective, and this research aims to understand how it benefits more patients.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that the MediBeacon Transdermal GFR System (tGFR) is safe and well-tolerated by patients. Previous studies found no serious side effects from using the device. The FDA has approved the system, indicating its safety for assessing kidney function in individuals with both healthy and impaired kidneys.
Specific safety data for Iohexol treatment is not available in the sources, but Iohexol is a widely used contrast agent and is generally considered safe for medical imaging. No specific safety information is provided for Relmapirazin. However, the clinical trial's Phase 4 status indicates that these treatments have been studied before and are generally considered safe for humans.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring because it offers a new, non-invasive way to measure kidney function. Unlike traditional methods, such as blood tests using substances like Iohexol, this technique utilizes a fluorescent probe that can be monitored through the skin, eliminating the need for blood draws. This method could provide real-time kidney health assessments, making it easier and more comfortable for patients to track their kidney function.
What evidence suggests that the MediBeacon tGFR monitor is effective for measuring kidney function?
Research has shown that the MediBeacon transdermal GFR (tGFR) system, which participants in this trial may receive, effectively measures kidney function. Studies indicate it accurately tracks the glomerular filtration rate (GFR), a key measure of kidney function. In one study, the tGFR system demonstrated 94% accuracy compared to traditional blood tests. This system offers a non-invasive method to monitor kidney function in real-time, which is particularly useful for patients with fluctuating kidney health. Additionally, the FDA has approved it for use in individuals with both normal and impaired kidney function.12467
Who Is on the Research Team?
Aaron M Cook, PharmD
Principal Investigator
University of Kentucky College of Pharmacy, Department of Pharmacy Practice & Science
Juan-Carlos Aycinena, MD
Principal Investigator
University of Kentucky College of Medicine, Department of Nephrology
Are You a Good Fit for This Trial?
This trial is for adults who are critically ill and may have increased kidney clearance. Participants must be hospitalized and able to undergo tests that measure kidney function. Specific inclusion or exclusion details are not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo transdermal GFR monitoring and comparison with urine creatinine clearance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Iohexol
- Medibeacon tGFR monitor
- Relmapirazin
Trial Overview
The study compares a new device (Medibeacon tGFR monitor) that measures kidney function through the skin with traditional methods like urine collection, blood tests using iohexol, relmapirazin, and creatinine clearance in critically ill patients.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aaron Cook
Lead Sponsor
Citations
MediBeacon® Transdermal GFR System Receives FDA ...
The TGFR Sensor records 2.5 fluorescent readings per second and the TGFR Monitor will display the average session tGFR reading at the patient's ...
Transdermal GFR System (TGFR) Clinician Brochure
The MediBeacon® Transdermal GFR System (TGFR) is engineered for non-invasive detection of the change in levels of a fluorescent GFR tracer agent ...
Accuracy of Point-of-Care Transdermal GFR Methodology - PMC
When compared with plasma-based GFR, this pivotal study yielded a P30 of 94.0% (95% CI: 89.4%–96.9%), exceeding the prespecified agreed upon FDA end point of a ...
NCT07349797 | MediBeacon® Transdermal GFR System ...
The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment using relmapirazin ...
Clinical
**The Transdermal GFR Measurement System (TGFR) is intended to measure Glomerular Filtration Rate (GFR) in patients with impaired or normal renal function.
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ifu.medibeacon.com
ifu.medibeacon.com/wp-content/uploads/2026/01/FACT-SHEET-Healthcare-Providers-Reusable_DOC1404v1-2025_12_LAUNCH.pdfFact Sheet for Healthcare Providers
This Fact Sheet informs you of the probable risks and benefits of the use of the MediBeacon®. Transdermal GFR System (TGFR). Indications for Use. The MediBeacon ...
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ifu.medibeacon.com
ifu.medibeacon.com/wp-content/uploads/2026/01/FACT-SHEET-Patients-TGFR-Reusable-Sensor-DOC1403v1-2025.12.15-LAUNCH.pdfFACT-SHEET-Patients-TGFR-Reusable-Sensor- ...
The MediBeacon® TGFR Reusable Sensor is intended to excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity.
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