Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · May 14, 2025

Keywords

ClinConnect Summary

The SAFE-LOW clinical trial is examining a new treatment approach for patients with ANCA-associated vasculitis, specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). This study aims to see if a low-dose glucocorticoid therapy combined with standard medications can safely and effectively treat patients, especially those with serious kidney issues. Researchers will compare this new treatment to the current standard care to determine which is better for patients.

To participate in this trial, individuals should be diagnosed with GPA or MPA, have specific kidney problems, and test positive for certain antibodies related to these conditions. The trial is open to all adults aged 18 and older. Participants can expect to receive close monitoring and support throughout the study, and their involvement will help researchers learn more about effective treatments for this serious illness. It's important to note that this trial is not yet recruiting participants, so there will be no immediate enrollment.

Gender

ALL

Eligibility criteria

• • 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