Actively Recruiting
Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)
Led by Ottawa Hospital Research Institute · Updated on 2026-01-30
36
Participants Needed
2
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- New diagnosis or relapse of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) as defined by Chapel-Hill consensus
- Positive ELISA test for anti-myeloperoxidase (MPO) or anti-proteinase 3 (PR3)
- Severe kidney involvement from active AAV with eGFR less than 40 ml/min/1.73m2
- Kidney biopsy showing necrotizing or crescentic glomerulonephritis or active urinary sediment by microscopy with specified red blood cell criteria
- Stable eGFR less than 40 ml/min/1.73m2 for more than 3 months prior to enrollment is not eligible
You will not qualify if you...
- Diagnosis of vasculitis types other than GPA or MPA
- Positive anti-glomerular basement membrane antibody or kidney biopsy showing linear immunoglobulin deposits
- Diagnosis of systemic lupus erythematosus or Sj�f6gren's syndrome
- Dialysis for more than 21 days before randomization or prior kidney transplant
- Age under 18 years
- Pregnant at screening
- Treatment with more than one IV dose of cyclophosphamide, more than 14 days of oral cyclophosphamide or prednisone over 30mg/day, or more than one dose of rituximab within 28 days prior to randomization
- Chronic viral infections including HIV, hepatitis B, or hepatitis C
- Untreated latent tuberculosis infection
- Active infection at presentation
- Other conditions that prevent use of glucocorticoids, cyclophosphamide, or rituximab as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
St-Joseph's Hospital
Hamilton, Ontario, Canada
Not Yet Recruiting
2
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
Research Team
D
David Massicotte-Azarniouch, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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