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
MediBeacon
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: To be eligible for study entry, all participants must satisfy all of the following criteria: 1. Age \> 18 years - male or female 1. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial 2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose 3. For women of child-bearing potential, the participant should have a negative pregnancy test, and agrees to one of the following acceptable contraceptive methods…
Interventions
- DeviceLumitrace
18.6 mg/mL in a 7.0 mL volume administered by intravenous injection over 30 - 60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 - 60 seconds
- DeviceMediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
Site staff will place and affix the TGFR reusable sensor and Disposable Ring for all enrolled participants. One sensor will be attached to the upper chest. An adhesive clip, surgical tape or other means may also be used to alleviate tension on the sensor cord. TGFR assessments will be collected for a minimum of 6 hours up to 8 hours post Lumitrace injection.
Location
- Fletcher Allen Health Care, University of Vermont Medical SchoolBurlington, Vermont