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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
Awards & highlights

Study Summary

This trial is testing a new way to measure kidney function. The new way uses a dye to measure how well the kidney is filtering blood. The trial will compare this new method to the current standard method. The trial will also evaluate the safety of the new method and dye.

Eligible Conditions
  • Chronic Kidney Disease

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR)
Secondary outcome measures
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

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 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be 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 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be collected over 24 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MB-102
2019
Completed Phase 3
~280
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
2023
Completed Phase 3
~380

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there positions available for new participants in this research?

"This trial appears to be open, as reflected on clinicaltrials.gov. It was first advertised on 6/1/2022 and has since been updated on 6/22/2022."

Answered by AI

In how many different geographic areas is this trial taking place?

"Patients can enroll at 5 different clinical locations such as Research by Design, LLC in Chicago, Carolina Phase I Research in Raleigh, Velocity Clinical Research in Edgewater."

Answered by AI

How many people are signed up to participate in this clinical trial?

"In total, 220 individuals who meet the prerequisites will be needed to partake in this clinical trial at various research sites such as Research by Design, LLC located in Chicago, Illinois and Carolina Phase I Research situated in Raleigh, North carolina."

Answered by AI

Has the MB-102 drug been cleared for use by the FDA?

"MB-102 has been evaluated for safety in multiple Phase 3 clinical trials, meaning that there is both efficacy and safety data available. Therefore, we have rated it as a 3 on our scale."

Answered by AI
~88 spots leftby Apr 2025