Aurinia Renal Response in Active Lupus With Voclosporin
Summary
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
Timeline
- Start
- 2017-05-17
- Primary completion
- 2019-09-24
- Completion
- 2019-10-10
Outcome
Met primary endpoint
registry analysis (superiority test); Voclosporin vs Placebo Oral Capsule; p <0.001; Odds Ratio (OR) 2.65 (95% CI 1.64 to 4.27); Regression, Logistic NCT03021499 ↗
paper The primary endpoint of complete renal response at week 52 was achieved in significantly more patients in the voclosporin group than in the placebo group PMID 33971155 ↗
release “AURORA 1 study demonstrated that voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks” otsuka.co.jp ↗
release “met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001).” auriniapharma.com ↗
release “AURORA met its primary endpoint” auriniapharma.com ↗
release “AURORA 1 met its primary endpoint, achieving statistically superior complete renal response rates of 41% in the LUPKYNIS group versus 23% in the control group” auriniapharma.com ↗
release “AURORA 1 demonstrated the clinical superiority of voclosporin with mycophenolate mofetil (MMF) and low-dose glucocorticoids compared to MMF and low-dose glucocorticoids alone.” auriniapharma.com ↗
release “AURORA 1 demonstrated the clinical superiority of voclosporin with mycophenolate mofetil (MMF) and low-dose glucocorticoids compared to MMF and low-dose glucocorticoids alone.” auriniapharma.com ↗
release “Significantly more patients in the voclosporin group achieved a CRR at 52 weeks of treatment” auriniapharma.com ↗
Publications
- Background Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM, Hooi LS, Brunetta P, Maciuca R, Solomons N. Lupus nephritis: induction therapy in severe lupus nephritis--should MMF be considered the drug of choice? Clin J Am Soc Nephrol. 2013 Jan;8(1):147-53. doi: 10.2215/CJN.03290412. Epub 2012 Aug 9.
- Background Ling SY, Huizinga RB, Mayo PR, Larouche R, Freitag DG, Aspeslet LJ, Foster RT. Cytochrome P450 3A and P-glycoprotein drug-drug interactions with voclosporin. Br J Clin Pharmacol. 2014 Jun;77(6):1039-50. doi: 10.1111/bcp.12309.
- Background Ling SY, Huizinga RB, Mayo PR, Freitag DG, Aspeslet LJ, Foster RT. Pharmacokinetics of voclosporin in renal impairment and hepatic impairment. J Clin Pharmacol. 2013 Dec;53(12):1303-12. doi: 10.1002/jcph.166. Epub 2013 Oct 8.
- Background Mayo PR, Huizinga RB, Ling SY, Freitag DG, Aspeslet LJ, Foster RT. Voclosporin food effect and single oral ascending dose pharmacokinetic and pharmacodynamic studies in healthy human subjects. J Clin Pharmacol. 2013 Aug;53(8):819-26. doi: 10.1002/jcph.114. Epub 2013 Jun 4.
- Results 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.
- Results Busque S, Cantarovich M, Mulgaonkar S, Gaston R, Gaber AO, Mayo PR, Ling S, Huizinga RB, Meier-Kriesche HU; PROMISE Investigators. The PROMISE study: a phase 2b multicenter study of voclosporin (ISA247) versus tacrolimus in de novo kidney transplantation. Am J Transplant. 2011 Dec;11(12):2675-84. doi: 10.1111/j.1600-6143.2011.03763.x. Epub 2011 Sep 22.
- Palmer BF, Tumlin JA, Radhakrishnan J, Rehaume LM, Cross JL, Huizinga RB. The kidney injury biomarker profile of patients with lupus nephritis remains unchanged with the second-generation calcineurin inhibitor voclosporin. Front Nephrol. 2025 Mar 17;5:1540471. doi: 10.3389/fneph.2025.1540471. eCollection 2025.
- Menn-Josephy H, Hodge LS, Birardi V, Leher H. Efficacy of Voclosporin in Proliferative Lupus Nephritis with High Levels of Proteinuria. Clin J Am Soc Nephrol. 2024 Mar 1;19(3):309-318. doi: 10.2215/CJN.0000000000000297. Epub 2023 Dec 18.
- Rovin BH, Teng YKO, Ginzler EM, Arriens C, Caster DJ, Romero-Diaz J, Gibson K, Kaplan J, Lisk L, Navarra S, Parikh SV, Randhawa S, Solomons N, Huizinga RB. Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2021 May 29;397(10289):2070-2080. doi: 10.1016/S0140-6736(21)00578-X. Epub 2021 May 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Voclosporin | Other / unclassified | 23.7 mg | Oral |