Not Yet RecruitingNot Applicable

Evaluation of Protein Loading on Measurement of Renal Reserve

United States25 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age \> 18 years - male or female
✓. Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial
✓. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose
✓. For women of child-bearing potential, the participant should have a negative pregnancy test, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization
✓. Men will not donate sperm during the study and for 1 month following the last dose of study drug
✓. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
✓. eGFR \>30 mL/min/1.73 m\^2
✓. Capable of fasting for at least 8 hours prior to the evaluation day

Exclusion criteria

What they're measuring

Renal reserve percentage

Timeframe: Day 1

Trial details

NCT IDNCT07335614

SponsorMediBeacon

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Richard B Dorshow, PhD

314-735-0968 rbdorshow@medibeacon.com

View on ClinicalTrials.gov More Glomerular Filtration Rate trials