Low-dose steroid treatment with standard induction medicines for ANCA-associated vasculitis affecting the kidneys

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SAFE-LOW compares a short, fixed 4-week glucocorticoid regimen given with standard induction therapy (cyclophosphamide or rituximab) against the current longer steroid taper used for ANCA-associated vasculitis with severe kidney involvement. Adults with new or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who are MPO- or PR3-positive and meet strict kidney criteria will be enrolled. The trial begins as a pilot to test feasibility of recruitment and adherence, then proceeds in a randomized phase 3 design to measure safety and effectiveness. Key outcomes include remission rates, kidney function, and steroid-related complications such as infections.

Why it matters

Who can join: the full rules

* 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

Where it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• St-Joseph's Hospital
  Hamilton, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: David Massicotte-Azarniouch, MD, MSc — The Ottawa Hospital
• Study coordinator: David Massicotte-Azarniouch, MD, MSc
• Email: damassicotte@toh.ca
• Phone: 613-738-8400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.