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

NCT06983821 Phase 3 RECRUITING

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.

Details

Lead sponsor	Ottawa Hospital Research Institute
Phase	Phase 3
Status	RECRUITING
Enrolment	36
Start date	2025-11-10
Completion	2029-02

Conditions

• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis (MPA)

Interventions

• Cyclophosphamide
• Standard of Care (SOC)
• Prednisone
• Rituximab (R)

Primary outcomes

• Pilot trial: percent adherence to intervention regimen — 12 weeks
  Pilot trial: percent adherence in the intervention arm (non-adherence will be defined as the use of more than 25% of the total expected oral prednisone in the intervention arm at 12 weeks)
• Full-scale trial: Rate of serious infection — 26 weeks
  Full-scale trial: rate of serious infection (Infection occurring after randomisation requiring IV antibiotics, or leading to hospitalisation or death)

Countries

Canada