Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)
Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW) Trial
Ottawa Hospital Research Institute
36 participants
Nov 10, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
IV Cyclophosphamide 15mg/kg/dose (age and eGFR adjusted), 2 doses 2 weeks apart
Participants will receive standard of care induction agent and glucocorticoid taper, at investigator discretion
4 weeks prednisone taper
Rituximab infusions, dosing and schedule at clinician/investigator discretion
Locations(2)
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NCT06983821