NCT07335614

An Open Label, Single Center Study to Evaluate the Effect of Protein Loading on the Measurement of Renal Reserve Using the MediBeacon® Transdermal GFR System

Not yet recruiting NA Last updated 31 March 2026

What this trial tests

NA trial testing Lumitrace in Glomerular Filtration Rate in 25 participants. Not yet recruiting.

Timeline

1 May 2026

Primary endpoint
1 January 2027

1 January 2027

Quick facts

Lead sponsor	MediBeacon
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	25
Start date	1 May 2026
Primary completion	1 January 2027
Estimated completion	1 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Lumitrace — full drug profile →
• MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Conditions studied

• Glomerular Filtration Rate — all drugs for Glomerular Filtration Rate →

Sponsor

MediBeacon — full company profile →

Who can join

18 and older, any sex, with Glomerular Filtration Rate. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Renal reserve percentage
  Time frame: Day 1
  Renal reserve (%) will be calculated as Peak glomerular filtration rate (GFR) during the assessment period minus the average baseline GFR/average baseline GFR.

Sponsor's own description

The goal of this clinical trial is to evaluate the effect of protein loading on the measurement of renal reserve using the MediBeacon Transdermal glomerular filtration rate (tGFR) system. Adults with estimated glomerular filtration rate (eGFR) \>30 ml/min/1.73 m\^2 will be recruited to join the study. This is a potential new use for the tGFR for the assessment of renal reserve. Renal reserve is the increase in GFR that occurs in response to various stimuli, such as when one kidney is removed. The remaining kidney will often show an increase in GFR to compensate. Renal reserve is typically measured after a high protein meal and requires a reproducible stimulus and a repeated measurement of GFR.

The main questions it aims to answer are:

* To characterize the effect of protein loading on GFR (dose response curve) as assessed by the MediBeacon Transdermal GFR System
* To determine Renal Reserve in participants with chronic kidney disease (CKD) using the MediBeacon Transdermal GFR System
* To demonstrate whether any change in GFR following the protein stimulus is associated with a change in cardiac output using non-invasive bioimpedance (NICaS)

Participants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and the initiation of GFR assessments, participants will ingest a high protein meal over 15-20 minutes. They will be followed at the study center for up to 6-8 hours following administration of Lumitrace. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace. Researchers will analyze the results to see if there is a detectable difference in fluorescence clearance rate following the high protein meal.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.