PEXIVAS (Version 1)

• Research type

  Research Study

• Full title

  Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial

• IRAS ID

  27957

• Sponsor organisation

  Addenbrooke's Hospital

• Eudract number

  2009-013220-24

• ISRCTN Number

  ISRCTN07757494

• Research summary

  Severe, anti-neutrophil cytoplasm antibody'ssociated vasculitis (AAV) is an uncommon disease of the immune system diagnosed in approximately 14-30 per 100,000 people in U.K. each year. ANCA associated vasculitis is important because it carries a poor prognosis with up to 50% of patients dying or developing kidney failure within 5 years. Two major problems hinder the treatment of ANCA associated vasculitis: 1) a lack of treatment strategies to bring the disease under control quickly before it causes major organ damage, and 2) a high degree of treatment related toxicity. We propose a randomised controlled trial to examine these problems in patients with severe ANCA associated vasculitis. Patients will be randomly assigned to receive plasma exchange (a method of rapidly removing harmful antibodies to promptly gain control of ANCA associated vasculitis) or to not receive plasma exchange. Patients will also be randomly assigned to receive either a standard dose of steroids or a low-dose scheme which is predicted to reduce treatment related toxicity. By addressing these problems we hope to significantly improve patient survival and reduce the frequency of kidney failure in patients with ANCA associated vasculitis.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0709/56

• Date of REC Opinion

  30 Oct 2009

• REC opinion

  Further Information Favourable Opinion