Status:
COMPLETED
CellCept in p-ANCA Vasculitis
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Roche Pharma AG
Conditions:
MPO-ANCA Vasculitis
Microscopic Polyangiitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Microscopic polyangiitis (MP) is a primary systemic vasculitis predominantly affecting small blood vessels. Following the widespread introduction of ANCA testing, the primary systemic vasculitis (SV),...
Detailed Description
1. Patients will receive I.V. methylprednisone, or I.V. dexamethazone, oral prednisone and oral MMF therapy as outlined in table 2. 2. MMF will be initiated within the first 1-2 weeks of the start of ...
Eligibility Criteria
Inclusion
- Active microscopic polyangiitis
- Active urinary sediment (\>25 rbc/hpf, red cell casts or dysmorphic red cells)
- Renal biopsy compatible with the diagnosis of microscopic polyangiitis, or diagnosis demonstrated by the presence of hematuria, proteinuria, and dysmorphic red blood cells, and / or red blood casts when biopsy is contraindicated.
- Positive p-ANCA (MPO ELISA)
- Serum creatinine \< 3.0mg/dl.
- Age 18 years or over.
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00405860
Start Date
December 1 2002
End Date
July 1 2008
Last Update
March 23 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905