NCT02141672

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Voclosporin is a next generation CNI intended for use in the prevention of organ graft rejection and for the treatment of autoimmune diseases. The aim of the current study is to investigate whether voclosporin added to the standard of care treatment in active LN is able to reduce disease activity, as measured by a reduction in proteinuria. Two doses of voclosporin will be studied and compared in a placebo controlled trial on a background of MMF and corticosteroids. Patients with active, flaring LN will be eligible to enter the study. They are required to have a diagnosis of LN according to established diagnostic criteria (American College of Rheumatology) and clinical and biopsy features suggestive of active nephritis. Efficacy will be assessed by the ability of the drug combination to reduce the level of proteinuria while demonstrating an acceptable safety profile.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Voclosporin High Dose
DRUG	Voclosporin Low Dose
DRUG	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-07-01
• Completion: 2017-01-01
• First posted: 2014-05-19
• Last updated: 2021-05-18
• Results posted: 2021-05-18

Locations

86 sites across 20 countries: United States, Bangladesh, Belarus, Bulgaria, China, Ecuador, Georgia, Guatemala, Mexico, Philippines, Poland, Russia, Serbia, Singapore, South Korea, Spain, Sri Lanka, Taiwan, Thailand, Ukraine