A randomized, controlled double-blind study comparing the efficacy and safety of dose-ranging voclosporin with placebo in achieving remission in patients with active lupus nephritis
Kidney International Nov 14, 2018
Rovin BH, et al. - In the phase 2, multicenter, randomized, double-blind, placebo-controlled AURA-LV study—which enrolled 265 participants from 79 centers in 20 countries—researchers assessed the efficacy and safety of the novel calcineurin inhibitor voclosporin in patients with active lupus nephritis (LN). They compared complete renal remission (CRR) at 24 weeks of treatment, between patients treated with two doses of voclosporin (23.7 mg or 39.5 mg, each twice daily) vs placebo in combination with mycophenolate mofetil (2 g/day) and rapidly tapered low-dose oral corticosteroids for induction therapy. They also evaluated CRR at 48 weeks. For induction therapy of active LN, they observed a superior renal response but higher rates of adverse events, including death, with the addition of low-dose voclosporin to mycophenolate mofetil and corticosteroids vs mycophenolate mofetil and corticosteroids alone.
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