NCT06983821RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 1 Apr 2025
- Start date
- 10 Nov 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- ANCA-associated vasculitis
- NCT number
- NCT06983821
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 36
- From 10 Nov 2025 to the primary completion date, Feb 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Age \<18
Other
- 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
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Joseph's Hospital Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.