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

PHASE3CompletedINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

June 14, 2022

Primary Completion Date

February 15, 2023

Study Completion Date

February 15, 2023

Conditions
Chronic Kidney Disease
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.

Trial Locations (8)

27612

Carolina Phase I Research, Raleigh

32132

Velocity Clinical Research, Edgewater

55114

Nucleus Network, Saint Paul

60643

Research by Design, LLC, Chicago

78240

Endeavor Clinical Trials, LLC, San Antonio

100034

Peking University First Hospital, Beijing

610093

West China Hospital of Sichuan University, Chengdu

2210029

Affiliated Hospital of Xuzhou Medical University, Xuzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MediBeacon

INDUSTRY