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GFR Measurement Agent

Non-Invasive Kidney Function Test for Kidney Disease

Phase 3
Recruiting
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 tests a new way to measure kidney function without a blood sample from people of all skin colors.

Who is the study for?
This trial is for adults with kidney issues who can consent and follow the study plan. Women must not be pregnant, have a negative pregnancy test, and use birth control; men also need to use contraception. People can't join if they've used tanning products recently, are on dialysis, had COVID-19 at dosing time, lost significant blood recently, taken NSAIDs close to dosing day or participated in another trial too soon before this one.Check my eligibility
What is being tested?
The study tests MB-102 (Relmapirazin) and MediBeacon's TGFR system that measures kidney function through the skin. It aims to show that this non-invasive method gives results similar to traditional plasma measurements across different skin types.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to drug infusion such as discomfort at the sensor site due to adhesive or sensitivity issues. The trial excludes those with severe allergic reactions suggesting possible risks of hypersensitivity.

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: Participants with eGFR ≥ 70 mL/min/1.73 m^2Experimental Treatment2 Interventions
MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
Group II: Participants with eGFR < 70 mL/min/1.73 m^2Experimental Treatment2 Interventions
MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR < 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
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
681 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this scientific research still available?

"Indeed, clinicaltrials.gov supports that this research initiative is currently recruiting candidates. This trial was first published on March 1st 2023 and has since been updated on the 22nd of the same month. 220 individuals from two sites are needed for enrollment."

Answered by AI

How many participants is this clinical trial currently accommodating?

"That is correct. As evidenced by clinicaltrials.gov, this medical experiment was originally posted on March 1st 2023 and it has since been modified for the last time on March 22nd of this year. The research necessitates 220 participants to be enrolled at two distinct sites."

Answered by AI

Is there a heightened level of risk for individuals with eGFR ≥ 70 mL/min/1.73 m^2?

"Our safety rating for participants with eGFR ≥ 70 mL/min/1.73 m^2 is 3, as this Phase 3 trial has established efficacy and multiple reports of safe outcomes."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Endeavor Clinical Trials, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Am interested in the alternate method to determine eGFR.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring
2023. "Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05777174.
~106 spots leftby Apr 2025
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