Protein Loading for Kidney Function Assessment
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
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.
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Who Is Running the Clinical Trial?
MediBeacon
Lead Sponsor
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