Protein Loading for Kidney Function Assessment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess how a high-protein meal affects kidney function measurements using the MediBeacon Transdermal Glomerular Filtration Rate Measurement System, which tracks filtration rates through the skin. It focuses on changes in kidney function and heart output among individuals with chronic kidney disease (CKD). Suitable candidates are adults who can refrain from certain medications and fast for at least 8 hours before testing. Participants should have a kidney function measure (eGFR) over 30 and be able to visit the study center for the required duration. As an unphased study, this trial allows participants to contribute to innovative research that could enhance future kidney disease management.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, like RAAS inhibitors or SGLT2 inhibitors, at least 5 half-lives before the study day. If you're on these or similar medications, discuss with the study team to see if you need to pause them.
What prior data suggests that the MediBeacon Transdermal GFR System is safe for assessing renal reserve?
Research shows that the Lumitrace injection, when used with the MediBeacon Transdermal GFR System, is generally safe. Studies found no serious or severe side effects. Common side effects include headaches, leakage at the injection site, and bruising, but these are usually mild. The FDA has approved the system for checking kidney function, indicating it has passed safety tests. Overall, the treatment appears well-tolerated for measuring kidney function.12345
Why are researchers excited about this trial?
Researchers are excited about the MediBeacon Transdermal Glomerular Filtration Rate (TGFR) Measurement System because it offers a non-invasive way to assess kidney function. Unlike traditional methods that require blood or urine samples, this system uses a sensor placed on the skin to measure kidney performance. This could make kidney monitoring easier and more comfortable for patients, potentially allowing for more frequent assessments without the need for needles or collecting samples.
What evidence suggests that the MediBeacon Transdermal GFR System is effective for assessing renal reserve?
Research has shown that the MediBeacon Transdermal GFR System, used by participants in this trial, effectively measures kidney function by tracking how quickly a substance called Lumitrace leaves the body. One study found the system to be 94% accurate, demonstrating high precision for most individuals. This accuracy remained consistent regardless of participants' kidney function levels. The system employs a special sensor to assess kidney performance through the skin, making the process easier and less invasive. This method has already received approval for assessing kidney function, confirming its effectiveness for this purpose.15678
Who Is on the Research Team?
Richard B Dorshow, PhD
Principal Investigator
MediBeacon, Inc.
Are You a Good Fit for This Trial?
Adults with kidney function above a certain level (eGFR >30 ml/min/1.73 m^2) can join this trial. They must be over 18, able to give informed consent, and follow the study rules. Women who can have children need a negative pregnancy test and use birth control; men also need to use contraception and not donate sperm during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous 130 mg dose of Lumitrace, followed by a high protein meal, and are monitored for 6-8 hours
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
- Lumitrace
- MediBeacon Transdermal Glomerular Filtration Rate Measurement System
Trial Overview
The trial is testing how eating a high-protein meal affects kidney performance using MediBeacon's tGFR system. Participants will eat protein, then researchers will track changes in their kidney filtration rate and heart output with Lumitrace injections and non-invasive methods.
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. Approximately three hours later, they will ingest a high protein meal consisting of approximately 1.25 g/kg in a protein shake over 15-20 minutes following a minimum of an 8 hour fast. They will be followed at the study center for up to 6-8 hours following administration of Lumitrace.
Find a Clinic Near You
Who Is Running the Clinical Trial?
MediBeacon
Lead Sponsor
Citations
summary of safety and effectiveness data (ssed)
The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of assessment of glomerular filtration rate (GFR) with ...
2.
innovate-ir.com
innovate-ir.com/news-releases/news-release-details/medibeaconr-next-generation-tgfrtm-system-receives-fda-approvalMediBeacon® Next Generation TGFR™ System Receives ...
The TGFR System enables kidney function assessment at the point of care by measuring the clearance rate of Lumitrace® (relmapirazin), a non- ...
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 ...
Accuracy of point-of-care transdermal glomerular filtration ...
P30 of 94% (95%CI 89-97%) was obtained for the entire cohort. P30 was 96% and 92% for participants with GFR greater than or less than 60 mL/min/ ...
Transdermal GFR System (TGFR) Clinician Brochure
Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal. GFR System (TGFR) for Glomerular ...
6.
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 most common side effects of Lumitrace injection include headache, tracer leakage and injection site bruising. These are not all the ...
7.
innovate-ir.com
innovate-ir.com/news-releases/news-release-details/medibeaconr-transdermal-gfr-system-receives-fda-approval-assessMediBeacon® Transdermal GFR System Receives FDA ...
In clinical studies no serious or severe adverse events have been observed. Lumitrace® injection has light absorbance at 266nm and 435nm, and ...
Point of Care GFR Assessment FACT SHEET FOR PATIENTS
common adverse reactions (incidence ≥ 1%) are injection site extravasation (2%), headache (1%) and ecchym osis (1%).
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