MediBeacon Transdermal GFR System for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new method for measuring kidney function in people with heart failure. The researchers seek to determine if the MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR), a device placed on the chest, accurately measures kidney filtration compared to standard blood tests. They are recruiting participants with symptomatic heart failure who experience issues like shortness of breath or fatigue and are not allergic to certain substances used in the study.
As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance kidney function assessment for heart failure patients.
What prior data suggests that the MediBeacon Transdermal GFR System is safe for heart failure patients?
Research has shown that the MediBeacon Transdermal GFR System, which uses Lumitrace, is designed to assess kidney function in adults. Although the system is approved for certain uses, it is not intended for individuals with very poor kidney function or those on dialysis, indicating its safety and effectiveness for other patients.
Lumitrace tracks its glow as it moves through the body to measure kidney function, offering an easier way to evaluate kidney performance.
Participants in this study will receive one dose of Lumitrace along with iohexol, a substance commonly used in imaging tests and generally considered safe. Researchers will closely monitor participants for 10 to 24 hours after the injection. While specific side effects are not listed, the careful monitoring and the system's design for adults emphasize safety. Prospective participants should consult their healthcare provider to determine if this study is suitable for them.12345Why are researchers excited about this trial?
The MediBeacon Transdermal GFR System is unique because it offers a non-invasive way to measure kidney function, which is crucial for managing heart failure. Current methods, like blood tests, can be invasive and time-consuming. This system uses a special sensor placed on the skin and a small dose of a fluorescent tracer, Lumitrace, to provide real-time data on kidney filtration without the need for repeated blood draws. Researchers are excited about this innovative approach because it could make monitoring kidney function safer, quicker, and more comfortable for patients.
What evidence suggests that the MediBeacon Transdermal GFR System is effective for heart failure?
Research has shown that the MediBeacon Transdermal GFR System can accurately measure kidney function, which is crucial for people with heart failure. In this trial, participants will receive a single intravenous 130 mg dose of Lumitrace followed by 1.5 mL of iohexol. The researchers will compare the system's kidney function readings to traditional methods. Previous studies found that the difference between the two methods was small, just 1.8 ml/min per 1.73 m², with results agreeing 78% of the time. This suggests the system is accurate and reliable for checking kidney function without invasive procedures.25678
Who Is on the Research Team?
Richard B Dorshow, PhD
Principal Investigator
MediBeacon, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with heart failure who are interested in testing a new way to measure kidney function. Participants must be available for a screening visit, a day-long study center follow-up, and a phone call after the test.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Lumitrace and iohexol, and the MediBeacon Transdermal GFR System is used to collect data
Follow-up
Participants are monitored for safety and effectiveness after treatment via a follow-up phone call
What Are the Treatments Tested in This Trial?
Interventions
- MediBeacon Transdermal Glomerular Filtration Rate Measurement System (tGFR)
Trial Overview
The trial tests the MediBeacon tGFR system using Lumitrace against traditional blood sampling methods (nGFRBSA) to see how well it measures kidney function in heart failure patients.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will have the tGFR sensor placed and background measurements initiated. Participants will then receive a single intravenous 130 mg dose of Lumitrace followed by 1.5 mL of iohexol. They will be followed at the study center for 10-24 hours.
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediBeacon
Lead Sponsor
Citations
MediBeacon® Transdermal GFR System for the Evaluation ...
The goal of this clinical trial is to evaluate the accuracy and feasibility of transdermal glomerular filtration rate (tGFR) assessment ...
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 ...
3.
innovate-ir.com
innovate-ir.com/news-releases/news-release-details/medibeaconr-next-generation-tgfrtm-system-receives-fda-approvalMediBeacon® Next Generation TGFR™ System Receives ...
In a phase 2 investigational study mGFR deduced from Lumitrace matched that of mGFR deduced from iohexol over a range of GFR values.
4.
medibeacon.com
medibeacon.com/medibeacon-transdermal-gfr-system-receives-fda-approval-to-assess-kidney-function/MediBeacon® Transdermal GFR System Receives FDA ...
Indication for Use: The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients ...
5.
journals.lww.com
journals.lww.com/jasn/fulltext/2025/08000/gfr_measurement_using_transdermal_detection.16.aspxGFR Measurement Using Transdermal Detection ...
We note tGFR performed well in reflecting plasma-derived nGFR with a small median difference of 1.8 ml/min per 1.73 m 2 and a 78% concordance in same GFR ...
summary of safety and effectiveness data (ssed)
The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR. >120 ml/min/1.73m2, patients on dialysis, or anuric patients.
Point of Care GFR Assessment FACT SHEET FOR PATIENTS
The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric ...
8.
ifu.medibeacon.com
ifu.medibeacon.com/wp-content/uploads/2025/01/TGFR-FACT-SHEET-Patients-DOC1386v0.pdfPoint of Care GFR Assessment FACT SHEET FOR ...
The MediBeacon® Transdermal GFR System (TGFR) is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or ...
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