MedTrace Logo

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

NCT05425719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 249

Last updated 2024-04-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

MB-102

18.6 mg/mL in a 7.0 mL volume administered by intravenous injection over 30 - 60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 - 60 seconds

DEVICE

MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)

On treatment day, participants had a transdermal sensor placed on their upper chest, and the MediBeacon Transdermal GFR Measurement System was initiated to collect background fluorescence. After collection of background fluorescence, participants received a single dose of MB-102.

Sponsors & Collaborators

  • MediBeacon

    lead INDUSTRY

Principal Investigators

  • Richard B Dorshow, PhD · MediBeacon, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2023-02-15
Completion
2023-02-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05425719 on ClinicalTrials.gov