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

  • STATUS
    Recruiting
  • participants needed
    245
  • sponsor
    MediBeacon
Updated on 1 August 2021
immunosuppressive agents
renal impairment
kidney function tests

Summary

This study is 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.

Description

The objectives of this study are 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.

Details
Condition Renal Failure, Acute renal failure, Kidney Failure (Pediatric), Kidney Failure, acute kidney injury, acute kidney injuries
Treatment Iohexol, MB-102, QuantumLeap, Radiance, Intravenous saline flush, Brilliance, MB-102-- single dose, MB-102-- two doses
Clinical Study IdentifierNCT02772276
SponsorMediBeacon
Last Modified on1 August 2021

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