At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 216 enrolled
Drug / intervention
Voclosporin +1 moredrug
Likely dose
Voclosporin 23.7 mgfrom 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, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis
In Brief
A Phase 3 clinical trial evaluating Voclosporin and Placebo Oral Capsule for Lupus Nephritis. Completed, enrolled 216 participants across 1 site.
Detailed Summary
The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLupus Nephritis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartSep 2019
Primary CompletionOct 2021
TodayJul 2026
First PostedJul 24, 2018
Enrollment StartSep 29, 2019
Primary CompletionOct 7, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.9 years ago
Interventions
Voclosporindrug
Calcineurin inhibitor, oral, 23.7 mg twice daily (BID)
Placebo Oral Capsuledrug
Voclosporin placebo, oral, 3 capsules twice daily (BID)