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Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)
Sponsor: Ottawa Hospital Research Institute
Summary
The purpose of this study is to determine the safety and efficacy of a therapeutic regimen consisting of 4 weeks of glucocorticoids given with a combination of the usual induction agents for ANCA-associated vasculitis. The trial will compare this regimen to the current standard of care treatment and glucocorticoid dosing for ANCA-associated vasculitis with severe kidney involvement. This trial will begin as a pilot to assess feasibility of recruitment and of adherence to the intervention.
Official title: Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW) Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2025-11-10
Completion Date
2029-02
Last Updated
2026-01-30
Healthy Volunteers
No
Interventions
Cyclophosphamide
IV Cyclophosphamide 15mg/kg/dose (age and eGFR adjusted), 2 doses 2 weeks apart
Standard of Care (SOC)
Participants will receive standard of care induction agent and glucocorticoid taper, at investigator discretion
Prednisone
4 weeks prednisone taper
Rituximab (R)
Rituximab infusions, dosing and schedule at clinician/investigator discretion
Locations (2)
St-Joseph's Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada