Rituxan in Churg Strauss Syndrome With Renal Involvement

Phase 2 Terminated 4 enrolled Fernando Fervenza Biogen · collab Genentech, Inc. · collab National Center for Research Resources (NCRR) · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.

Timeline

Start: 2007-06
Primary completion: 2009-07
Completion: 2009-07

Outcome

Met primary endpoint

Stopped (Business): “Company providing study drug terminated study due to lack of funds”

paper All achieved the primary end point of renal remission within the first 3 months PMID 21325353 ↗

Publications

Results Cartin-Ceba R, Keogh KA, Specks U, Sethi S, Fervenza FC. Rituximab for the treatment of Churg-Strauss syndrome with renal involvement. Nephrol Dial Transplant. 2011 Sep;26(9):2865-71. doi: 10.1093/ndt/gfq852. Epub 2011 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	375 mg/m2	—
Background	Prednisone	Other / unclassified	1 mg/kg	—