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Fluorophore

MB-102 for Chronic Kidney Disease

Q: 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.

Q: 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.

Q: 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, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a> and Carolina Phase I Research situated in Raleigh, <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>.

Q: 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.

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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values

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

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

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

MB-102

2019

Completed Phase 3

~280

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

2023

Completed Phase 3

~370

Do I qualify?Apply below to find out

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

Recent research and studies

clinicaltrials.govStudy

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

2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05425719.