March 2013: This clinical trial is enrolling patients.
PEXIVAS: An International Randomized Controlled Clinical Trial Assessing Plasma Exchange and Steroid Dosing in the Treatment of Severe Anti-Neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis
The PEXIVAS study is the largest clinical trial ever to be conducted for vasculitis. The study will study 500 patients with ANCA-associated vasculitis with granulomatosis (GPA/Wegener’s) or microscopic polyangiitis and test the usefulness of plasma exchange for the treatment of vasculitis. The European Vasculitis Study Group and the VCRC are combining efforts on this study.
The treatments used for ANCA vasculitis aim to suppress the immune system but may have significant side effects. Conventional treatment of AAV with glucocorticoids (“steroids,” such as prednisone or prednisolone) and cyclophosphamide is generally effective but the drugs have serious side effects and do not always put patients in remission. An additional treatment called plasma exchange (PLEX) has been used which aims to rapidly remove ANCA and other substances involved in the immune system reactions in the blood. Although recent clinical trials in AAV have shown that PLEX helps patients with the most severe kidney disease, it is not known how long the benefit of PLEX lasts or whether patients with less severe kidney disease or lung hemorrhage may also benefit from this treatment.
Goals of PEXIVAS: What will the researchers hope to learn?
This PEXIVAS study aims to determine how effective PLEX is at helping patients with kidney involvement or lung hemorrhage survive, achieve disease control, and prevent kidney failure. If successful, PLEX could then become a routine treatment for this type of ANCA vasculitis.
The trial will also compare a standard glucocorticoid (“steroid”) dose to a reduced dose regimen as it is not clear what the best and safest dose of glucocorticoids is for AAV. It is important to use the correct dose in order to balance their benefits with their side effects, especially infections. Steroids work effectively by suppressing the overactive immune cells that are causing disease activity.
Regardless of its outcome, this trial is likely to change the treatment practices of patients with severe ANCA vasculitis.
Who will be studied?
PEXIVAS will enroll 500 patients (adults, and adolescents aged between 15-18 years) with ANCA-associated vasculitis affecting their kidneys and/or lungs. The trial will take place in over 50 hospitals in the UK, other EU countries, the USA, Canada, Australia, and New Zealand.
The PEXIVAS principal investigators are:
• Peter Merkel, MD, MPH (Boston, USA)
• Michael Walsh, MD (Calgary, Canada)
• David Jayne, MD (Cambridge, UK)
Study update as of 2012: 62 centres around the world are active.
• 15 United Kingdom (UK) centres are active and recruiting, with six more awaiting activation.
• 12 European Union (EU) centres are active with 8 more awaiting activation.
• Spain, France and Germany are planning to participate in the study.
• Canada has 7 centres active, and hopes to add at least 2 more in the next year.
• United States has 8 active centres with 2 more centres joining soon.
• Mexico has opened and recruited its first patient.
• 16 centres in Australia are now active
• 3 in New Zealand are now active.