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COMPLETED Phase 3

Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring

NCT05777174 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from estimated glomerular filtration rate (eGFR) \<120 to \>15 mL/min/1.73 m2 and spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study. The main questions that the study aimed to answer were: * To establish that the MB-102 transdermal fluorescence assessed GFR using the MediBeacon Transdermal GFR System with the TGFR reusable sensor with disposable adhesive ring was comparable to the measured MB-102 plasma GFR. * To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR System and the TGFR reusable sensor with disposable adhesive ring for the non-invasive transdermal fluorescence detection of MB-102 in participants On dosing day, participants had the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. When this was completed, participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- or 24-hour (or longer) period, depending upon enrollment group. For those with significant renal compromise, fluorescent measurements were continued until the sensor no longer detected MB-102 in the body. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR.

Interventions

  • DRUG MB-102
  • DEVICE MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

Study Locations (5)

Texas

  • PPD — Austin
  • Clinical Advancement Center, PLLC — San Antonio
  • Endeavor Clinical Trials, LLC — San Antonio

Illinois

  • Research by Design, LLC — Chicago

Ohio

  • Centricity Research — Columbus

Trial Details

FieldValue
Enrollment Target 149 participants
Start Date 2023-03-20
Est. Completion 2024-04-15
Phase Phase 3

Sponsor

MediBeacon

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05777174

The ClinicalTrials.gov registry entry for NCT05777174 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediBeacon, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Kidney Diseases appearing as the primary indexed condition, and to 2 interventions — of which MB-102 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05777174 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Texas, Illinois, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05777174 about?

NCT05777174 is a clinical study titled "Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring". The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from estimated glomerular filtration rate (eGFR) \<120 to \>15 mL/min/1.73 m2...

What is the current status of trial NCT05777174?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 149 participants. The study started on 2023-03-20. Estimated completion is 2024-04-15.

What conditions does trial NCT05777174 study?

This clinical trial studies the following conditions: Kidney Diseases, Kidney Failure, Kidney Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05777174?

The interventions under investigation include: MB-102 (DRUG), MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05777174?

This trial is sponsored by MediBeacon, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05777174 being conducted?

This trial has 5 study locations across Illinois, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial