Trial Outcomes & Findings for Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring (NCT NCT05777174)

Last Updated: 2025-03-28

Results Overview

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 across all participants. 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 97% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 97% CI greater than 0.85.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

149 participants

Primary outcome timeframe

Up to 24 hours following the study dose

Results posted on

2025-03-28

Participant Flow

Safety Population: all participants who enrolled in the study and were dosed with MB-102

Participant milestones

Participant milestones
Measure	Participants With eGFR ≥ 70 mL/Min/1.73 m^2 A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.	Participants With eGFR < 70 mL/Min/1.73 m^2 A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.
Overall Study STARTED	84	65
Overall Study COMPLETED	84	65
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With eGFR ≥ 70 mL/Min/1.73 m^2 n=84 Participants A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.	Participants With eGFR < 70 mL/Min/1.73 m^2 n=65 Participants A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.	Total n=149 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 12.9 • n=5 Participants	66.0 years STANDARD_DEVIATION 8.62 • n=7 Participants	57.8 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	32 Participants n=7 Participants	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	26 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	39 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	26 Participants n=5 Participants	31 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	52 Participants n=5 Participants	30 Participants n=7 Participants	82 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours following the study dose

Population: Modified intent-to-measure population (all participants enrolled in the study for whom an average session tGFR or an average snapshot tGFR had been calculated, with no major protocol deviations and no outlier pharmacokinetic parameters)

Outcome measures

Outcome measures
Measure	Participants With eGFR ≥ 70 mL/Min/1.73 m^2 n=40 tGFR values A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.	Participants With eGFR < 70 mL/Min/1.73 m^2 n=35 tGFR values A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.
Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR)	0.950 Proportion of tGFR within 30% of nGFR Interval 0.817 to 0.995	0.971 Proportion of tGFR within 30% of nGFR Interval 0.836 to 1.0

SECONDARY outcome

Timeframe: From the time of dosing through the follow-up visit, up to 10 days

Population: Safety Population: all participants who enrolled in the study and were dosed with MB-102

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.

Outcome measures

Outcome measures
Measure	Participants With eGFR ≥ 70 mL/Min/1.73 m^2 n=84 Participants A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.	Participants With eGFR < 70 mL/Min/1.73 m^2 n=65 Participants A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.
Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From the time of dosing through the follow-up visit, up to 10 days

Population: Safety Population: all participants who enrolled in the study and were dosed with MB-102

Outcome measures

Outcome measures
Measure	Participants With eGFR ≥ 70 mL/Min/1.73 m^2 n=84 Participants A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.	Participants With eGFR < 70 mL/Min/1.73 m^2 n=65 Participants A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.
Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device	0 Participants	0 Participants

Adverse Events

Participants With eGFR ≥ 70 mL/Min/1.73 m^2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Participants With eGFR < 70 mL/Min/1.73 m^2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With eGFR ≥ 70 mL/Min/1.73 m^2 n=84 participants at risk A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 12 hours.	Participants With eGFR < 70 mL/Min/1.73 m^2 n=65 participants at risk A TGFR Reusable Sensor with Disposable Adhesive Ring was placed on participants' chests at least 15 minutes prior to dosing on treatment day, and the MediBeacon Transdermal GFR System was initiated to collect background fluorescence. After the collection of background fluorescence, a single dose of MB-102 (130 mg) was administered intravenously to participants with estimated glomerular filtration rate eGFR \< 70 mL/min/1.73 m\^2. Approximately half of the participants had Fitzpatrick Scale Type I, II or III, and half had Type IV, V and VI skin color type. Blood samples and fluorescent measurements were collected over 24 hours.
General disorders INJECTION SITE EXTRAVASATION	0.00% 0/84 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	3.1% 2/65 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Nervous system disorders HEADACHE	2.4% 2/84 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.00% 0/65 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Vascular disorders HYPERTENSION	0.00% 0/84 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	4.6% 3/65 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days

Additional Information

Richard B Dorshow, PhD

MediBeacon, Inc.

Phone: 314-735-0967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee MediBeacon requests that no presentation/publication occur until after the first publication of study results or until 1 yr after a study is completed/terminated early, whichever occurs first. Proposed results publication/disclosure must be given to Sponsor for review at least 45 days prior to the date of submission. If a patent application is to be filed, both the Institution and the Sponsor will defer publication or other disclosure for a period of time, not to exceed an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER