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A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg BID, or 39.5 mg BID) With Placebo in Achieving Remission in Patients With Active Lupus Nephritis (AURA-LV)
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.
Details
| Lead sponsor | Aurinia Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 265 |
| Start date | 2014-06 |
| Completion | 2017-01 |
Conditions
- Lupus Nephritis
Interventions
- Voclosporin High Dose
- Voclosporin Low Dose
- Placebo
Primary outcomes
- Number of Subjects Achieving Complete Renal Remission at 24 Weeks — week 24
Complete remission is defined as: * Confirmed protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥60 mL/min/1.73m2 or no confirmed decrease from baseline in eGFR of ≥20%. Subjects who received rescue medication for lupus nephritis or \>10 mg prednisone for \>3 consecutive days or \>7 days total from 56 days prior to remission assessment until the time of the remission assessment were considered not achieving complete remission.
Countries
United States, Bangladesh, Belarus, Bulgaria, China, Ecuador, Georgia, Guatemala, Mexico, Philippines, Poland, Russia, Serbia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, Ukraine