Evaluation of Protein Loading on Measurement of Renal Reserve

Part of paid clinical trials in Burlington, Vermont.

Sponsor
MediBeacon
Study ID
NCT07335614
Status
Not Yet Recruiting

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Conditions

  • Glomerular Filtration Rate

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lumitrace — DEVICE
    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
  • MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: 130 mg Lumitrace
    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.

Primary Outcome Measure

Renal reserve percentage [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fletcher Allen Health Care, University of Vermont Medical SchoolBurlingtonVermont05401
Richard J Solomon, MD

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By research site
Fletcher Allen Health Care, University of Vermont Medical School· Burlington, VT

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