PEXIVAS Trial

Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis: an international randomised controlled trial.

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Study Design

Multi-centre, international, open label, factorial design, randomised control trial in severe ANCA-associated vasculitis (AAV). Five hundred participants will be randomised, 1:1, to receive adjunctive plasma exchange (PLEX) in addition to standard immunosuppressive therapy and glucocorticoids (GC) or standard immunosuppressive therapy and GC without PLEX. The same 500 patients will be randomised, 1:1, to receive reduced-dose GC taper or standard-dose GC taper. 

We are very pleased to announce that the first patient was randomised into PEXIVAS on Tuesday 8th June 2010 from Addenbrooke's Hospital, Cambridge, UK.  


 

Trial Chief Investigator: David Jayne (UK and Europe), Peter A. Merkel (USA) and Michael Walsh (Canada)

Sponsor: Cambridge University Hospitals NHS Foundation Trust

Funding: National Institutes of Health Research (UK): Number, HTA 08/56/04, Food and Drug Administration/National Institutes of Health (USA): FDA R01 FD003516 and the National Institutes of Health (USA) - National Institute of Arthritis and Musculoskeletal and Skin Diseases: U54 AR0573319, National Health and Medical Research Council (Australia): 626939 and Canadian Institutes of Health Research (Canada): 211079.

EudraCT Number: 2009-013220-24

REC Outer West London: 09/H0709/56

MHRA: CTA Ref. 21857/0006/001-0001

ISRCTN07757494