AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

Summary

To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.

Timeline

Start

2014-06

Primary completion

2016-07

Completion

2017-01

Outcome

Met primary endpoint

registry analysis (superiority test); Voclosporin Low Dose; p = 0.045; Odds Ratio (OR) 2.03 (95% CI 1.01 to 4.05); Regression, Logistic NCT02141672 ↗

Publications

• Background Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.
• Background Appel GB, Contreras G, Dooley MA, Ginzler EM, Isenberg D, Jayne D, Li LS, Mysler E, Sanchez-Guerrero J, Solomons N, Wofsy D; Aspreva Lupus Management Study Group. Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. J Am Soc Nephrol. 2009 May;20(5):1103-12. doi: 10.1681/ASN.2008101028. Epub 2009 Apr 15.
• Anders HJ, Chan TM, Sanchez-Guerrero J, Wofsy D, Bensley K, Kim L, Lo KH, Shu C, Shao J, Karyekar CS, Diamond B. Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a phase 2, randomized, placebo-controlled study. Rheumatology (Oxford). 2025 May 1;64(5):2731-2740. doi: 10.1093/rheumatology/keae647.

Drugs

Indications