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
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Cyclophosphamide
IV Cyclophosphamide 15mg/kg/dose (age and eGFR adjusted), 2 doses 2 weeks apart
Standard of Care (SOC)
Participants will receive standard of care induction agent and glucocorticoid taper, at investigator discretion
Prednisone
4 weeks prednisone taper
Rituximab (R)
Rituximab infusions, dosing and schedule at clinician/investigator discretion