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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00424749
Other study ID # 06-004767
Secondary ID UL1RR024150
Status Terminated
Phase Phase 2
First received January 19, 2007
Last updated November 3, 2011
Start date June 2007
Est. completion date July 2009

Study information

Verified date November 2011
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


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Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab
Patients received 4 weekly doses of rituximab 375 mg/m^2.
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

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (4)

Lead Sponsor Collaborator
Fernando Fervenza Biogen, Genentech, Inc., National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Participants With Remission of Renal Disease Activity at 3 Months 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) 3 months after beginning of remission induction regimen No
Secondary Participants With Normalization of Eosinophil Count at 6 Months Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L. 6 months after beginning of remission induction regimen No
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