Glomerular Filtration RateNCT07335614
Evaluation of Protein Loading on Measurement of Renal Reserve
A study testing Lumitrace and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) in people with Glomerular Filtration Rate, run by MediBeacon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glomerular Filtration Rate
- What is being tested?
- Lumitrace and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for study entry, all participants must satisfy all of the following 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
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- 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
Who cannot join
- Current use of renin-angiotensin-aldosterone system inhibitors (RAASi) including angiotensin-receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACE-inhibitors) or direct renin inhibitors that can't be stopped at least 5 half-lives prior to the study day.
- Current use of sodium-glucose cotransporter-2 (SGLT2) inhibitors such as bexaglifloxin, canagliflozin, dapagliflozin, empagliflozin, ertugliflozin or others that can't be stopped at least 5 half-lives prior to the study day.
- Currently taking any drug classified as a sympathomimetic drug such as dobutamine, dopamine, norepinephrine, epinephrine, isoproterenol or others.
- Current over the counter use of cold medications containing ephedrine or weight loss drugs containing ephedra alkaloids
- Current history of drug use involving cocaine, mephedrone, amphetamines or methamphetamine
- The participant has participated in a clinical trial and has received an investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (whichever duration is longer).
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- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
- History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered a drug allergy).
- Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial.
- Significant scarring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin
- Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks of dosing day
- Use make-up, lotions, Vaseline or other products on the upper chest on the day prior to or the day of assessments
- Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the subjects' ability to complete study requirements or may put the subject at increased risk or compromise the interpretability of study results.
- Participants with positive pregnancy test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fletcher Allen Health Care, University of Vermont Medical School
Burlington, Vermont, 05401
Richard J Solomon, MD
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- Glomerular Filtration Rate
- Being tested
- Lumitrace, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Keywords
- Relmapirazin, Lumitrace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumitraceDevice
Also called Relmapirazin
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 group | Role | What they receive |
|---|---|---|
| 130 mg Lumitrace | Experimental | 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. Receives: Device: Lumitrace; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal reserve percentage
Renal reserve (%) will be calculated as Peak glomerular filtration rate (GFR) during the assessment period minus the average baseline GFR/average baseline GFR.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerular Filtration RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediBeacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Dorshow, PhD, Study director, MediBeacon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335614
- Sponsor's protocol ID
- 100-301
- Status last verified
- Aug 2026
- First submitted
- 23 Dec 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07335614
- Acronym / sponsor ID
- 100-301
- Conditions
- Glomerular Filtration Rate
- Keywords
- Relmapirazin, Lumitrace
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 130 mg Lumitrace | Experimental | Device: Lumitrace, Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To be eligible for study entry, all participants must satisfy all of the following criteria:
- Age > 18 years - male or female
- 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
Key exclusion criteria (14 listed)
- Current use of renin-angiotensin-aldosterone system inhibitors (RAASi) including angiotensin-receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACE-inhibitors) or direct renin inhibitors that can't be stopped at least 5 half-lives prior to the study day.
- Current use of sodium-glucose cotransporter-2 (SGLT2) inhibitors such as bexaglifloxin, canagliflozin, dapagliflozin, empagliflozin, ertugliflozin or others that can't be stopped at least 5 half-lives prior to the study day.
- Currently taking any drug classified as a sympathomimetic drug such as dobutamine, dopamine, norepinephrine, epinephrine, isoproterenol or others.
- Current over the counter use of cold medications containing ephedrine or weight loss drugs containing ephedra alkaloids
- Current history of drug use involving cocaine, mephedrone, amphetamines or methamphetamine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumitraceAlso: Relmapirazin18.6 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 | Device | 130 mg Lumitrace |
| MediBeacon 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. | Device | 130 mg Lumitrace |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard B Dorshow, PhD study director
MediBeacon, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumitrace and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) in people with Glomerular Filtration Rate, run by MediBeacon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard B Dorshow, PhD (314-735-0968, rbdorshow@medibeacon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal reserve percentage (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.