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NCT03597464 · ClinicalTrials.gov registry record · Phase 3
Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
A Phase 3 study, sponsored by Aurinia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 216
- Enrollment target
NCT03597464: Completed Phase 3 study, sponsored by Aurinia Pharmaceuticals.
NCT03597464 is a Phase 3 study that has completed, run by Aurinia Pharmaceuticals. The registered enrollment target is 216 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03597464, a Phase 3 study, has completed, sponsored by Aurinia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 216 participants
- Enrollment target
Study 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).
Primary Outcome
Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To 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 LN.
Interventions
- DRUG Placebo Oral Capsule
- DRUG Voclosporin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2019-09-29 |
| Est. Completion | 2021-10-07 |
| Phase | Phase 3 |
What the finished NCT03597464 record still lists
NCT03597464 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Capsule is the first listed.
NCT03597464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03597464 about?
NCT03597464 is a clinical study titled "Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin". 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).
What is the current status of trial NCT03597464?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 216 participants. The study started on 2019-09-29. Estimated completion is 2021-10-07.
What interventions are being tested in trial NCT03597464?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Voclosporin (DRUG).
Who is sponsoring clinical trial NCT03597464?
This trial is sponsored by Aurinia Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03597464's enrollment target sits among peer trials
216 1332nd of 2000 higher than 667 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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