Plasma Exchange and glucocorticoids in anti-neutrophil cytoplasm antibody associated vasculitis: a randomized controlled trial. PEXIVAS
- Conditions
- Granulomatosis With Polyangiitis (Wegener's) (GPA) Microscopic Polyangiitis (MPA)
- Registration Number
- JPRN-UMIN000009523
- Brief Summary
Ref:N Engl J Med. 2020;382:622-631.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 704
Not provided
1. A diagnosis of vasculitis other than granulomatosis with polyangiitis or microscopic polyangiitis 2. Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition 3. Receipt of dialysis for >21 days immediately prior to randomization or prior renal transplant 4. Age <18 years 5. Pregnancy/Inability or unwillingness to comply with birth control 6. Treatment with >1 IV dose of cyclophosphamide and/or >14 days of oral cyclophosphamide and/or >14 days of prednisone/prednisolone (>30 mg/day) and/or >1 dose of rituximab within the 28 days immediately prior to randomization 7. A comorbidity or condition that, in the opinion of the investigator,precludes the use of cyclophosphamide/rituximab, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange 8. Plasma exchange in 3 months prior to randomization
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of i)all-cause mortality or ii) End-stage renal disease
- Secondary Outcome Measures
Name Time Method *Sustained remission *Rate of serious infections *Health-related quality of life using the SF-36 Physical Composite, Mental Composite and EQ-5D Index Score