MB-102 for Chronic Kidney Disease (CKD)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Nucleus Network, Saint Paul, MN
Chronic Kidney Disease (CKD)+2 More
MB-102 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a multi-center, open-label, pivotal study comparing transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) with MB-102 (relmapirazin) as the fluorophore. Participants will span the GFR range of values from normal to stage 4 chronic kidney disease (CKD) and span the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS). The safety and pharmacokinetics of MB-102 and the safety of the MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) will also be evaluated.

Eligible Conditions

  • Chronic Kidney Disease (CKD)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 24 hours

Up to 10 days
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
Up to 24 hours
Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

eGFR < 70 mL/min/1.73 m^2
1 of 2
eGFR ≥ 70 mL/min/1.73 m^2
1 of 2
Experimental Treatment

220 Total Participants · 2 Treatment Groups

Primary Treatment: MB-102 · No Placebo Group · Phase 3

eGFR < 70 mL/min/1.73 m^2Experimental Group · 2 Interventions: MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) · Intervention Types: Drug, Device
eGFR ≥ 70 mL/min/1.73 m^2Experimental Group · 2 Interventions: MB-102, MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) · Intervention Types: Drug, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MB-102
2019
Completed Early Phase 1
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 hours
Closest Location: Nucleus Network · Saint Paul, MN
2008First Recorded Clinical Trial
1 TrialsResearching Chronic Kidney Disease (CKD)
69 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are not of child-bearing potential or willing to use adequate contraception during the trial.
You are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol.
You have adequate venous access for blood sampling per protocol requirements.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.