Plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis: a multicentre randomized controlled trial (PEXIVAS)
Principal Investigator: Patrick Nachman, MD
Sponsor: Food and Drug Administration
Age Range: 18 years of age and above
Purpose: This is a multi-center, international research study in severe ANCA-associated vasculitis to determine the efficacy of plasma exchange in addition to immunosuppressive therapy and glucocorticoids in reducing death and end-stage renal disease. The study will also evaluate the efficacy of a reduced-dose glucocorticoids regimen in reducing death and end-stage renal disease.
Study Procedures: Participants will be randomized to receive either plasma exchange or no plasma exchange and either a standard glucocorticoid dose or a low glucocorticoid dose. All patients will receive standard immunosuppressive induction therapy with cyclophosphamide or rituximab.
Participation: Participation in the study will last between 2 and 7 years. Participants will have 7 study visits the first year and then 2 study visits each year until the end of the study (minimum 9-maximum 19 visits in total). Each visit will last approximately half an hour.
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