Chronic Kidney DiseasePhase 3NCT05425719
Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects
A Phase 3 study testing MB-102 and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) in people with Chronic Kidney Disease, run by MediBeacon at 8 sites in 2 countries.
Trial summary
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- MB-102 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
- 249 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 14 Jun 2022to 15 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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 serum pregnancy test at screening, 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
- Adequate venous access sufficient to allow blood sampling per protocol requirements
Who cannot join
- Participants positive via PCR testing for COVID-19 (Vaccinated participants without symptoms of COVID-19 are not required to undergo PCR testing but may be tested at the discretion of the study site)
- Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
- Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing
- 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)
- 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, MB-102 or other related products (intolerance to a drug is not considered a drug allergy).
Show all 13Show fewer
- 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
- 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 participant's ability to complete study requirements or may put the participant at increased risk or compromise the interpretability of study results.
- Currently receiving dialysis
- Currently anuric
- Positive serum pregnancy test
- Participants with an eGFR > 120 mL/min/1.73m^2
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States5 sites
Research by Design, LLC
Chicago, Illinois, 60643
Velocity Clinical Research
Edgewater, Florida, 32132
Carolina Phase I Research
Raleigh, North Carolina, 27612
Nucleus Network
Saint Paul, Minnesota, 55114
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78240
China3 sites
Peking University First Hospital
Beijing, 100034
West China Hospital of Sichuan University
Chengdu, Sichuan, 610093
Affiliated Hospital of Xuzhou Medical University
Xuzhou, 2210029
About this study
Official title: A Pivotal, Open Label, Multi-Center, Safety and Pharmacokinetic Study of MB-102 (Relmapirazin) and the Use of the MediBeacon Transdermal GFR Measurement System in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from normal to Stage 4 chronic kidney disease (CKD) and participants spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study.
The main questions that the study aimed to answer were:
Read more
- To establish that the MB-102 transdermal fluorescence measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR
- To evaluate the safety and tolerability of a single dose of MB-102 in study participants
- To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System (TGFR) for the non-invasive transdermal fluorescence detection of MB-102 in participants
Participants had a transdermal sensor placed on their upper chest, and the TGFR collected background fluorescence. Participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR in those with and without normal kidney function and different skin coloration.
- Conditions
- Chronic Kidney Disease
- Being tested
- MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
- Keywords
- Glomerular Filtration Rate, Transdermal fluorescence detection, Relmapirazin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-102Drug
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
On treatment day, participants had a transdermal sensor placed on their upper chest, and the MediBeacon Transdermal GFR Measurement System was initiated to collect background fluorescence. After collection of background fluorescence, participants received a single dose of MB-102.
| Study group | Role | What they receive |
|---|---|---|
| eGFR ≥ 70 mL/min/1.73 m^2 | Experimental | Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours. Receives: Drug: MB-102; Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) |
| eGFR < 70 mL/min/1.73 m^2 | Experimental | Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours. Receives: Drug: MB-102; 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.
Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values
The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 95% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 95% CI greater than 0.85.
Measured: Up to 24 hours following the study dose
Secondary outcomes (2)
Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.
Measured: From the time of dosing through the follow-up visit, up to 10 days
Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.
Measured: From the time of dosing through the follow-up visit, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start14 Jun 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
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
- NCT05425719
- Sponsor's protocol ID
- MB-100-003
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2022
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Brady CT, Lieske JC, Kashani K, Sas DJ, Romero MF. Comparative Analysis of GFR Measurement Techniques: Part 2. Current GFR Measurements. Kidney360. 2026 Oct 1;7(10):2403-2411. doi: 10.34067/KID.0000001177. Epub 2026 Feb 13.
PubMed 41686514Chan G, Pino CJ, Johnston KA, Humes HD. Estimating Changes in Glomerular Filtration Rate With Fluorescein Isothiocyanate-Sinistrin During Renal Replacement Therapy. ASAIO J. 2023 Aug 1;69(8):810-815. doi: 10.1097/MAT.0000000000001947. Epub 2023 Apr 27.
PubMed 37104481
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Open Label, Multi-Center, Safety and Pharmacokinetic Study of MB-102 (Relmapirazin) and the Use of the MediBeacon Transdermal GFR Measurement System in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function
- ClinicalTrials.gov ID
- NCT05425719
- Acronym / sponsor ID
- MB-100-003
- Conditions
- Chronic Kidney Disease
- Keywords
- Glomerular Filtration Rate, Transdermal fluorescence detection, Relmapirazin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 18 Apr 2024
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 was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from normal to Stage 4 chronic kidney disease (CKD) and participants spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study.
The main questions that the study aimed to answer were:
- To establish that the MB-102 transdermal fluorescence measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR
- To evaluate the safety and tolerability of a single dose of MB-102 in study participants
- To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System (TGFR) for the non-invasive transdermal fluorescence detection of MB-102 in participants
Participants had a transdermal sensor placed on their upper chest, and the TGFR collected background fluorescence. Participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR in those with and without normal kidney function and different skin coloration.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eGFR ≥ 70 mL/min/1.73 m^2 | Experimental | Drug: MB-102, Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours. |
| eGFR < 70 mL/min/1.73 m^2 | Experimental | Drug: MB-102, Device: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 serum pregnancy test at screening, 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
Key exclusion criteria (13 listed)
- Participants positive via PCR testing for COVID-19 (Vaccinated participants without symptoms of COVID-19 are not required to undergo PCR testing but may be tested at the discretion of the study site)
- Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
- Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing
- 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)
- History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
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 |
|---|---|---|
| MB-102Also: 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 | Drug | eGFR < 70 mL/min/1.73 m^2, eGFR ≥ 70 mL/min/1.73 m^2 |
| MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)On treatment day, participants had a transdermal sensor placed on their upper chest, and the MediBeacon Transdermal GFR Measurement System was initiated to collect background fluorescence. After collection of background fluorescence, participants received a single dose of MB-102. | Device | eGFR < 70 mL/min/1.73 m^2, eGFR ≥ 70 mL/min/1.73 m^2 |
Primary outcome
Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values
Time frame: Up to 24 hours following the study dose
The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 95% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 95% CI greater than 0.85.
2 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration
Time frame: From the time of dosing through the follow-up visit, up to 10 days
Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device
Time frame: From the time of dosing through the follow-up visit, up to 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41686514Brady CT, Lieske JC, Kashani K, Sas DJ, Romero MF. Comparative Analysis of GFR Measurement Techniques: Part 2. Current GFR Measurements. Kidney360. 2026 Oct 1;7(10):2403-2411. doi: 10.34067/KID.0000001177. Epub 2026 Feb 13.
- Derived from this study: PubMed 37104481Chan G, Pino CJ, Johnston KA, Humes HD. Estimating Changes in Glomerular Filtration Rate With Fluorescein Isothiocyanate-Sinistrin During Renal Replacement Therapy. ASAIO J. 2023 Aug 1;69(8):810-815. doi: 10.1097/MAT.0000000000001947. Epub 2023 Apr 27.
- 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. This study is not recruiting at the moment.
Richard B Dorshow, PhD study director
MediBeacon, Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MB-102 and MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) in people with Chronic Kidney Disease, run by MediBeacon at 8 sites in 2 countries.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values (time frame: Up to 24 hours following the study dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05425719, which also lists 2 linked publications.
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 18 Apr 2024.