Status:
NOT_YET_RECRUITING
Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Granulomatosis With Polyangiitis
Microscopic Polyangiitis (MPA)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-asso...
Detailed Description
ANCA-associated vasculitis (AAV) is an auto-immune disease which often involves the kidneys. It is a serious condition as it can lead to severe kidney impairment, often kidney failure, and may even be...
Eligibility Criteria
Inclusion
- 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 Criteria (any of the following)
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06983821
Start Date
August 1 2025
End Date
February 1 2029
Last Update
July 31 2025
Active Locations (2)
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1
St-Joseph's Hospital
Hamilton, Ontario, Canada
2
The Ottawa Hospital
Ottawa, Ontario, Canada