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The AURA-LV trial assessed voclosporin, a calcineurin inhibitor in patients with active lupus nephritis (LN) and found that low-dose voclosporin may be successfully added to mycophenolate mofetil and corticosteroids to controll active LN.
A total of 265 lupus nephritis patients were enrolled from 79 worldwide centers in this Phase 2, randomized, double-blind, placebo-controlled trial of two doses of voclosporin (23.7 mg or 39.5 mg, given twice daily) versus placebo in patients already taking mycophenolate and steroids. The primary endpoint was CRR at 24 weeks; the secondary endpoint was CRR at 48 weeks.
By week 24, a complete renal response (CRR) was achieved in 27-32% on voclosporin and 19% in the placebo group. A significantly higher CRR rate was seen in the low-dose voclosporin group out to 48 weeks.
Serious adverse events were higher in the voclosporin and more deaths in the low-dose group compared to placebo and high-dose voclosporin groups.
These data sugggest the efficacy of low dose voclosporin in LN but adverse events may limit its ultimate fate.
More trials are in progress.