CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 234 enrolled
Drug / intervention
MB-102-- single dose of 4 µmol/kg +8 moredrug
Likely dose
MB-102-- single dose of 130 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02772276
NCT02772276Phase 2Completed
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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

MediBeacon·interventional·Posted May 13, 2016·Updated Oct 26, 2023

In Brief

A Phase 2 clinical trial evaluating MB-102-- single dose of 4 µmol/kg, MB-102-- single dose of 130 mg, and 7 other interventions for Acute Kidney Injury. Completed, enrolled 234 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Kidney Injury
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 13, 2016
Enrollment StartMay 11, 2016
Primary CompletionAug 4, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.1 years ago

Interventions

MB-102-- single dose of 4 µmol/kgdrug

4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

MB-102-- single dose of 130 mgdrug

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.

MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apartdrug

130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

MB-102-- two doses of 130 mg 24 hours apartdrug

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.

Iohexoldrug

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

QuantumLeapdevice

Optical Renal Function Monitor (ORFM)

Radiancedevice

Optical Renal Function Monitor (ORFM)

Brilliance (1 or 2 sensors)device

Optical Renal Function Monitor (ORFM)

Brilliance (2-part sensor)device

Optical Renal Function Monitor (ORFM)