Tests lower-dose steroid treatment in people with ANCA-associated vasculitis
Compares a short steroid course with standard treatment in adults with kidney-involved vasculitis.
Plain-language title generated from the registry record
Registry title: Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)
Key facts
- Where
- Hamilton and Ottawa, CanadaSee the 2 sites
- Phase
- Phase 3
Where in Canada
- St. Joseph's HospitalHamilton, CanadaNot yet recruiting
- The Ottawa HospitalOttawa, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ottawa Hospital Research Institute
- Trial code
- NCT06983821
- Record updated
- 30 January 2026
- Original description
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.Read full original descriptionShow less
Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW) Trial
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.
Exclusion: Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition; Receipt of dialysis for >21 days immediately prior to randomization or prior renal transplant; Treatment with >1 IV dose of CYC and/or >14 days PO CYC and/or >14 days of prednisone/prednisone (less than or equal to 30mg/day) and/or >1 dose of RTX within the 28 days immediately prior to randomization; A diagnosis of systemic lupus erythematosus or Sjögren's syndrome; Chronic viral infection: HIV. HBV or HCV; Untreated latent mycobacterium tuberculosis infection; Active infection at time of presentation; A comorbidity or condition that, in the opinion of the investigator, precludes the use of GC, CYC or RTX; Age <18; A diagnosis of vasculitis other than GPA or MPA (including eosinophilic granulomatosis with polyangiitis, IgA vasculitis, cryoglobulinemic vasculitis, rheumatoid vasculitis); Pregnant at time of screening.
New diagnosis of, or relapse of, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill consensus definitions; Positive ELISA test for anti-meyloperoxidase (MPO) or anti-proteinase 3 (PR3); Severe kidney involvement from active AAV, characterised by both of the following:; eGFR < 40ml/min/1.73m2 (Patients known to have a stable eGFR <40 ml/min/1.73m2 for >3 months prior to enrollment are NOT eligible); Biopsy proven at least focal necrotizing/crescentic glomerulonephritis OR active urinary sediment by microscopy (greater than or equal to 10 red blood cells [RBC]/high power field with erythrocyte casts or greater than or equal to 20% dysmorphic RBCs or greater than or equal to 5% acanthocytes without an alternative cause.