Nephrosphere

A French group in the NEJM performed an open-label multicenter trial of patients with ANCA vasculitis (Wegener’s or MPA) comparing remission maintenance with azathioprine (Imuran) or methotrexate. All 126 patients had remission induced with IV steroids and cyclophosphamide prior to maintenance treatment. The study was 12 months long and the primary endpoint was an adverse event requiring study drug termination or death. There were no differences between the group in the primary endpoint, or in secondary endpoints (serious adverse effects or relapse). As the primary endpoint suggests, the main goal was to compare safety, rather than efficacy, but relapse rates were nearly identical as well.