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SAFE-LOW
NCT06983821Phase 3Recruiting
- Sponsor
- Ottawa Hospital Research Institute
- Start
- Nov 2025
- Primary completion
- Feb 2028
- Modality
- Monoclonal Antibodies, Orthosteric Ligands
- Countries
- 1
01
Overview
Phase 3, randomised, open-label trial of cyclophosphamide, rituximab and prednisone in Antineutrophil cytoplasmic antibody-associated vasculitis (AAV), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (2 arms), sponsored by Ottawa Hospital Research Institute. Primary endpoints: Percent adherence to intervention regimen at 12 weeks and Rate of serious infection at 26 weeks. Started Nov 2025; status: recruiting.
02
Drugs
cyclophosphamiderituximabprednisone
03
Conditions
Antineutrophil cytoplasmic antibody-associated vasculitis (AAV)granulomatosis with polyangiitis (GPA)microscopic polyangiitis (MPA)
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