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

Phase 2 Completed 234 enrolled MediBeacon

Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start: 2016-05-11
Primary completion: 2021-08-04
Completion: 2021-08-04

Publications

Dorshow RB, Debreczeny MP, Goldstein SL. GFR Measurement Using Transdermal Detection Methodology. J Am Soc Nephrol. 2025 Feb 7;36(8):1592-1602. doi: 10.1681/ASN.0000000639.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iohexol	Diagnostic / imaging agent	5 ml	Intravenous
Subject	Relmapirazin	Diagnostic / imaging agent	0.004 mmol	Intravenous
Subject	Relmapirazin	Diagnostic / imaging agent	130 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications