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Fluorophore

MB-102 for Chronic Kidney Disease

Phase 3
Waitlist Available
Research Sponsored by MediBeacon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours following the study dose
Awards & highlights

Summary

This trial tests a glowing dye and a sensor to measure kidney function through the skin. It includes adults with different kidney health levels and skin colors. The goal is to see if this new method is as accurate as traditional blood tests. Recent advances in technology to measure fluorescent compounds through the skin are providing a new approach for real-time measurement of kidney function.

Eligible Conditions
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours following the study dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours following the study dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values
Secondary study objectives
Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration
Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device

Side effects data

From 2023 Phase 3 trial • 249 Patients • NCT05425719
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
eGFR ≥ 70 mL/Min/1.73 m^2
eGFR < 70 mL/Min/1.73 m^2

Trial Design

2Treatment groups
Experimental Treatment
Group I: eGFR ≥ 70 mL/min/1.73 m^2Experimental Treatment2 Interventions
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.
Group II: eGFR < 70 mL/min/1.73 m^2Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
2023
Completed Phase 3
~370
MB-102
2019
Completed Phase 3
~280

Find a Location

Who is running the clinical trial?

MediBeaconLead Sponsor
8 Previous Clinical Trials
651 Total Patients Enrolled
Richard B Dorshow, PhDStudy DirectorMediBeacon, Inc.
4 Previous Clinical Trials
278 Total Patients Enrolled
~77 spots leftby Sep 2025