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
Inclusion Criteria5
- 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.
Exclusion Criteria11
- A diagnosis of vasculitis other than GPA or MPA (including eosinophilic granulomatosis with polyangiitis, IgA vasculitis, cryoglobulinemic vasculitis, rheumatoid vasculitis)
- Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition
- A diagnosis of systemic lupus erythematosus or Sjögren's syndrome
- Receipt of dialysis for \>21 days immediately prior to randomization or prior renal transplant
- Age \<18
- Pregnant at time of screening
- 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
- 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
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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)
View Full Details on ClinicalTrials.gov
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NCT06983821