NCT03021499

Aurinia Renal Response in Active Lupus With Voclosporin

A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg Twice Daily) With Placebo in Achieving Renal Response in Subjects With Active Lupus Nephritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of the current study is to investigate whether voclosporin, added to the standard of care treatment in active lupus nephritis (LN), is able to reduce disease activity over a treatment period of 52 weeks. The background therapy will be mycophenolate mofetil (MMF) and initial treatment with IV methylprednisolone, followed by a reducing course of oral corticosteroids. Subjects 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 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 (as measured by Urine Protein Creatinine Ratio (UPCR)) while demonstrating an acceptable safety profile.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Voclosporin	calcineurin inhibitor
DRUG	Placebo Oral Capsule	matching placebo capsule

Timeline

• Start date: 2017-05-17
• Primary completion: 2019-09-24
• Completion: 2019-10-10
• First posted: 2017-01-16
• Last updated: 2023-03-27
• Results posted: 2021-06-16

Locations

185 sites across 31 countries: United States, Argentina, Belarus, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Dominican Republic, Guatemala, Japan, Malaysia, Mexico, Netherlands, North Macedonia, Peru, Philippines, Poland, Puerto Rico, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, Vietnam

Regulatory

• FDA-regulated drug study