Trial Outcomes & Findings for 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 (NCT NCT05425719)

Last Updated: 2024-04-18

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. 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

249 participants

Primary outcome timeframe

Up to 24 hours following the study dose

Results posted on

2024-04-18

Participant Flow

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

Participant milestones

Participant milestones
Measure	eGFR ≥ 70 mL/Min/1.73 m^2 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 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.
Overall Study STARTED	130	119
Overall Study COMPLETED	125	118
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	eGFR ≥ 70 mL/Min/1.73 m^2 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 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.
Overall Study Lost to Follow-up	4	0
Overall Study Withdrew consent	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	eGFR ≥ 70 mL/Min/1.73 m^2 n=130 Participants 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 n=119 Participants 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.	Total n=249 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 14.19 • n=5 Participants	61.5 years STANDARD_DEVIATION 13.45 • n=7 Participants	53.9 years STANDARD_DEVIATION 15.63 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	45 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	74 Participants n=7 Participants	142 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants	14 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants	103 Participants n=7 Participants	197 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	37 Participants n=5 Participants	27 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	33 Participants n=5 Participants	43 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	49 Participants n=7 Participants	107 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours following the study dose

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

Outcome measures

Outcome measures
Measure	eGFR ≥ 70 mL/Min/1.73 m^2 n=90 Participants 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 n=92 Participants 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.	All Participants n=182 Participants Participants 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 - 24 hours.
Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values	0.96 Proportion of tGFR within 30% of nGFR Interval 0.89 to 0.99	0.92 Proportion of tGFR within 30% of nGFR Interval 0.85 to 0.97	0.94 Proportion of tGFR within 30% of nGFR Interval 0.89 to 0.97

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	eGFR ≥ 70 mL/Min/1.73 m^2 n=130 Participants 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 n=119 Participants 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.	All Participants Participants 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 - 24 hours.
Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration	1 Participants	0 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	eGFR ≥ 70 mL/Min/1.73 m^2 n=130 Participants 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 n=119 Participants 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.	All Participants Participants 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 - 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

eGFR ≥ 70 mL/Min/1.73 m^2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

eGFR < 70 mL/Min/1.73 m^2

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	eGFR ≥ 70 mL/Min/1.73 m^2 n=130 participants at risk 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 n=119 participants at risk 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.
Investigations Cardiac murmur	0.00% 0/130 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	1.7% 2/119 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Nervous system disorders Headache	2.3% 3/130 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	0.84% 1/119 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/130 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	1.7% 2/119 • 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% 0/130 • Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days	1.7% 2/119 • 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