Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation

Phase 1/2 Completed 20 enrolled Cedars-Sinai Medical Center Biogen · collab Genentech, Inc. · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to examine the safety and efficacy of IVIG in combination with Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a transplanted organ in patients who are highly HLA-sensitized and are awaiting transplantation.

Timeline

Start: 2005-09
Primary completion: 2007-05
Completion: 2007-05

Publications

Vo AA, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, Peng A, Villicana R, Jordan SC. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008 Jul 17;359(3):242-51. doi: 10.1056/NEJMoa0707894.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	1 g	Intravenous
Subject	intravenous immune globulin	Unknown	2 g/kg	Intravenous

Indications

No indication recorded.