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NCT05777174 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Kidney Diseases and Kidney Failure, sponsored by MediBeacon.
- Completed
- Registry status
- Phase 3
- Development phase
- 149
- Enrollment target
- 5
- Study locations
NCT05777174 is a Phase 3 study of Kidney Diseases and Kidney Failure that has completed, run by MediBeacon. The registered enrollment target is 149 participants, below the 1,782-participant average among 38 other Kidney Diseases trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 3 states.
The verdict
NCT05777174, a Phase 3 study of Kidney Diseases and Kidney Failure, has completed, sponsored by MediBeacon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 149 participants
- Enrollment target
- 5
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2023-03-20 |
| Est. Completion | 2024-04-15 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,782-participant average among 38 other Kidney Diseases trials with a reported enrollment target (92% lower). The listed sponsor is MediBeacon, which has 11 total studies on file at ClinicalTrials.gov.
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.
NCT05777174 reports 5 study locations spanning 3 distinct geographic areas - top geographies include Texas, Illinois, Ohio.
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.
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).
Who is sponsoring clinical trial NCT05777174?
This trial is sponsored by MediBeacon, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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