NCT02949973

Aurinia Early Urinary Protein Reduction Predicts Response

An Exploratory Study Assessing the Short Term Predictors of Remission of Voclosporin 23.7mg Twice Daily (BID) in Combination With Standard of Care in Patients With Active Lupus Nephritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An exploratory study assessing the ability of biomarkers measured at 8 weeks to predict clinical response over 24 and 48 weeks in subjects taking voclosporin 23.7 mg twice daily (BID) in combination with standard of care in patients with active lupus nephritis

Detailed description

Voclosporin is a novel calcineurin inhibitor (CNI) intended for use in the prevention of organ graft rejection and for the treatment of autoimmune diseases. The aim of the current development program is to investigate whether voclosporin added to the standard of care treatment in active Lupus Nephritis (LN) is able to reduce disease activity, as measured by a reduction in proteinuria. The background therapy will be mycophenolate mofetil (MMF) 2 g daily, initial treatment with IV methylprednisolone followed by a reducing course of oral 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

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-12-01
• Completion: 2017-02-17
• First posted: 2016-10-31
• Last updated: 2021-03-19
• Results posted: 2021-03-19

Locations

2 sites across 1 country: Malaysia