At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 358 enrolled
Drug / intervention
Voclosporin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Voclosporin and Placebo Oral Capsule for Lupus Nephritis. Completed, enrolled 358 participants across 185 sites in 31 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesArgentina, 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, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMay 2017
Primary CompletionSep 2019
Study CompletionOct 2019
TodayJul 2026
First PostedJan 16, 2017
Enrollment StartMay 17, 2017
Primary CompletionSep 24, 2019
Study CompletionOct 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.5 years ago
Interventions
Voclosporindrug
calcineurin inhibitor
Placebo Oral Capsuledrug
matching placebo capsule