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

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT06983821
Phase
PHASE3
Status
Recruiting
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Conditions

  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis (MPA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    IV Cyclophosphamide 15mg/kg/dose (age and eGFR adjusted), 2 doses 2 weeks apart
  • Standard of Care (SOC) — DRUG
    Participants will receive standard of care induction agent and glucocorticoid taper, at investigator discretion
  • Prednisone — DRUG
    4 weeks prednisone taper
  • Rituximab (R) — DRUG
    Rituximab infusions, dosing and schedule at clinician/investigator discretion

Study Details

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.

Key Dates

Start date
Nov 10, 2025
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm
    IV Cyclophosphamide x 2 doses AND Rituximab AND Prednisone x 4 weeks
  • Active Comparator: Standard of care
    Participants in this arm receive standard of care treatment induction agent and glucocorticoid dose/duration, left to the discretion of the investigator

Primary Outcome Measure

Pilot trial: percent adherence to intervention regimen [ Time Frame: 12 weeks ]

Central Contacts

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