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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours following the study dose

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

Headache

100%

80%

60%

40%

20%

Study treatment Arm

eGFR ≥ 70 mL/Min/1.73 m^2

eGFR < 70 mL/Min/1.73 m^2

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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