NCT00424749

Rituxan in Churg Strauss Syndrome With Renal Involvement

A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Fernando Fervenza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of Rituximab in inducing remission of renal disease activity in patients with CSS.

Conditions

• Churg-Strauss Syndrome

Interventions

Type	Name	Description
DRUG	Rituximab	Patients received 4 weekly doses of rituximab 375 mg/m\^2.
DRUG	Prednisone	Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-01-22
• Last updated: 2011-12-08
• Results posted: 2011-12-08

Locations

1 site across 1 country: United States