NCT05777174

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

Completed Phase 3 Results posted Last updated 28 March 2025

What this trial tests

Phase 3 trial testing MB-102 in Kidney Diseases in 149 participants. Completed in 15 April 2024.

Timeline

20 March 2023

Primary endpoint
15 April 2024

15 April 2024

Quick facts

Lead sponsor	MediBeacon
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	149
Start date	20 March 2023
Primary completion	15 April 2024
Estimated completion	15 April 2024
Sites	5 locations across United States

Drugs / interventions tested

• MB-102 — full drug profile →
• MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Conditions studied

• Kidney Diseases — all drugs for Kidney Diseases →
• Kidney Injury — all drugs for Kidney Injury →
• Kidney Failure — all drugs for Kidney Failure →

Sponsor

MediBeacon — full company profile →

Who can join

18 and older, any sex, with Kidney Diseases or Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Primary · 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 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.

Group	Value	95% CI
Participants With eGFR ≥ 70 mL/Min/1.73 m^2	0.950	0.817 – 0.995
Participants With eGFR < 70 mL/Min/1.73 m^2	0.971	0.836 – 1.00

Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration Secondary · From the time of dosing through the follow-up visit, up to 10 days

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.

Group	Value	95% CI
Participants With eGFR ≥ 70 mL/Min/1.73 m^2	1
Participants With eGFR < 70 mL/Min/1.73 m^2	1

Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device Secondary · From the time of dosing through the follow-up visit, up to 10 days

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.

Group	Value	95% CI
Participants With eGFR ≥ 70 mL/Min/1.73 m^2	0
Participants With eGFR < 70 mL/Min/1.73 m^2	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events were collected from the time of dosing through the follow-up visit, up to 10 days. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

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

Serious: 0/84 (0%)

Deaths: 0/84

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

Serious: 0/65 (0%)

Deaths: 0/65

Other adverse events (3 terms — click to expand)

Reaction	System	Participants With eGFR ≥ 7…	Participants With eGFR < 7…
HYPERTENSION	Vascular disorders	—	—
INJECTION SITE EXTRAVASATION	General disorders	—	—
HEADACHE	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT05777174 adverse events section.

Sponsor's own description

The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from estimated glomerular filtration rate (eGFR) \<120 to \>15 mL/min/1.73 m2 and 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 assessed GFR using the MediBeacon Transdermal GFR System with the TGFR reusable sensor with disposable adhesive ring was comparable to the measured MB-102 plasma GFR.
* To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR System and the TGFR reusable sensor with disposable adhesive ring for the non-invasive transdermal fluorescence detection of MB-102 in participants

On dosing day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. When this was completed, participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- or 24-hour (or longer) period, depending upon enrollment group. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.