NCT02772276

Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types

A Pilot Safety and Pharmacokinetic Study of MB-102 Versus Iohexol and the Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: MediBeacon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study was a pilot, safety, and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor (ORFM) device in normal and compromised renal function participants with different skin color types.

Detailed description

The objectives of this study were to evaluate the safety and tolerability of single and multiple doses of MB-102 in participants with normal and impaired kidney function; to determine plasma pharmacokinetics of MB-102 compared to the pharmacokinetics of iohexol in participants with normal and impaired kidney function; to demonstrate that MB-102-transdermal-fluorescence-measured glomerular filtration rate (GFR) using the optical renal function monitor (ORFM) Brilliance device is aligned with MB-102 plasma GFR; to evaluate the safety and effectiveness of the ORFM investigational medical device prototypes QuantumLeap, Radiance, and Brilliance for the non-invasive transdermal fluorescent detection of MB-102 in participants with a range of skin color types; and to determine the optimal dose of MB-102 for non-invasive measurement.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	MB-102-- single dose of 4 µmol/kg	4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.
DRUG	MB-102-- single dose of 130 mg	130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.
DRUG	MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart	130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.
DRUG	MB-102-- two doses of 130 mg 24 hours apart	4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.
DRUG	Iohexol	5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds
DEVICE	QuantumLeap	Optical Renal Function Monitor (ORFM)
DEVICE	Radiance	Optical Renal Function Monitor (ORFM)
DEVICE	Brilliance (1 or 2 sensors)	Optical Renal Function Monitor (ORFM)
DEVICE	Brilliance (2-part sensor)	Optical Renal Function Monitor (ORFM)

Timeline

• Start date: 2016-05-11
• Primary completion: 2021-08-04
• Completion: 2021-08-04
• First posted: 2016-05-13
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study