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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

NCT02772276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2023-10-26

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • MediBeacon

    lead INDUSTRY

Principal Investigators

  • Richard B Dorshow, PhD · MediBeacon, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2021-08-04
Completion
2021-08-04
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

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 NCT02772276 on ClinicalTrials.gov