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NCT05425719 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by MediBeacon.
- Completed
- Registry status
- Phase 3
- Development phase
- 249
- Enrollment target
NCT05425719 is a Phase 3 study that has completed, run by MediBeacon. The registered enrollment target is 249 participants.
The verdict
NCT05425719, a Phase 3 study, has completed, sponsored by MediBeacon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 249 participants
- Enrollment target
Study Summary
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from normal to Stage 4 chronic kidney disease (CKD) and participants 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 measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR * To evaluate the safety and tolerability of a single dose of MB-102 in study participants * To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System (TGFR) for the non-invasive transdermal fluorescence detection of MB-102 in participants Participants had a transdermal sensor placed on their upper chest, and the TGFR collected background fluorescence. Participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period. 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 in those with and without normal kidney function and different skin coloration.
Interventions
- DRUG MB-102
- DEVICE MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 249 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05425719
The ClinicalTrials.gov registry entry for NCT05425719 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 249 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediBeacon, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MB-102 is the first listed.
NCT05425719 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05425719 about?
NCT05425719 is a clinical study titled "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". The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from normal to Stage 4 chronic kidney disease (CK...
What is the current status of trial NCT05425719?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 249 participants. The study started on 2022-06-14. Estimated completion is 2023-02-15.
What interventions are being tested in trial NCT05425719?
The interventions under investigation include: MB-102 (DRUG), MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) (DEVICE).
Who is sponsoring clinical trial NCT05425719?
This trial is sponsored by MediBeacon, which has 11 total clinical trials registered on ClinicalTrials.gov.
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