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Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)

Study acronym: SAFE-LOW
StatusRecruiting
PhasePhase 3
Started2025-11-10
View on ClinicalTrials.gov ↗

Amendment history

2026-01-28
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-08→confirmed 2025-11-10
Study sitesdetails revised at 2 of 2 sites
2025-07-28
Study Status, Arms and Interventions, Outcome Measures v1
Start date2025-05→2025-08
2025-05-14
Original filing
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.
Trial Details
NCT Number NCT06983821
Lead Sponsor Ottawa Hospital Research Institute
Conditions Granulomatosis With Polyangiitis, Microscopic Polyangiitis (MPA)
Enrollment 36 participants
Start Date 2025-11-10
Primary Completion 2028-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-30