Clinical Trial: Rituxan in Churg Strauss Syndrome With Renal Involvement

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Fernando Fervenza

Current Primary Outcome: Participants With Remission of Renal Disease Activity at 3 Months [ Time Frame: 3 months after beginning of remission induction regimen ]

Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)


Original Primary Outcome:

  • Safety of Rituximab in patients with Churg-Strauss
  • Remission of renal disease activity as indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever is smalle


Current Secondary Outcome: Participants With Normalization of Eosinophil Count at 6 Months [ Time Frame: 6 months after beginning of remission induction regimen ]

Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.


Original Secondary Outcome: Normalization of eosinophil count at six months. Normalization is defined as total eosinophil counts <1.5 x 109/l.

Information By: Mayo Clinic

Dates:
Date Received: January 19, 2007
Date Started: June 2007
Date Completion:
Last Updated: November 3, 2011
Last Verified: November 2011