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NCT03021499 · ClinicalTrials.gov registry record · Phase 3
Aurinia Renal Response in Active Lupus With Voclosporin
A Phase 3 study of Lupus Nephritis, sponsored by Aurinia Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 358
- Enrollment target
- 20
- Study locations
NCT03021499: Completed Phase 3 study of Lupus Nephritis, sponsored by Aurinia Pharmaceuticals.
NCT03021499 is a Phase 3 study of Lupus Nephritis that has completed, run by Aurinia Pharmaceuticals. The registered enrollment target is 358 participants, above the 298-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03021499, a Phase 3 study of Lupus Nephritis, has completed, sponsored by Aurinia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 358 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary efficacy endpoint was the number of subjects showing renal response at Week 52. Renal response was adjudicated based on blinded data by an independent Clinical Endpoints Committee based on meeting the following criteria * UPCR of ≤0.5 mg/mg \& * eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of \>20% \& * Received no rescue medication for LN \& * Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during Weeks 44 through
Conditions Studied
Interventions
- DRUG Placebo Oral Capsule
- DRUG Voclosporin
Study Locations (20)
Florida
- AURORA Investigative Center - Clearwater
- AURORA Investigative Center - DeBary
- AURORA Investigative Center - Fort Lauderdale
- AURORA Investigative Center - Fort Myers
- AURORA Investigative Center - Miami
- AURORA Investigative Center - Orlando
- AURORA Investigative Center - Winter Park
California
- AURORA Investigative Center - Beverly Hills
- AURORA Investigative Center - Los Angeles
- AURORA Investigative Center - Los Angeles
- AURORA Investigative Center - Palo Alto
- AURORA Investigative Center - Thousand Oaks
- AURORA Investigative Center - Torrance
Arizona
- AURORA Investigative Center - Phoenix
- AURORA Investigative Center - Phoenix
Colorado
- AURORA Investigative Center - Aurora
- AURORA Investigative Center - Denver
Alabama
- AURORA Investigative Center - Huntsville
Connecticut
- AURORA Investigative Center - New Haven
Georgia
- AURORA Investigative Center - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 358 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2019-10-10 |
| Phase | Phase 3 |
What the finished NCT03021499 record still lists
NCT03021499 is an interventional study that assigns participants to a tested intervention. The registered 358 participants enrollment target is mid-sized for trials with a published cap, above the 298-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Capsule is the first listed.
NCT03021499 names 20 study sites across 7 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT03021499 about?
NCT03021499 is a clinical study titled "Aurinia Renal Response in Active Lupus With Voclosporin". 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.
What is the current status of trial NCT03021499?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 358 participants. The study started on 2017-05-17. Estimated completion is 2019-10-10.
What conditions does trial NCT03021499 study?
This clinical trial studies the following conditions: Lupus Nephritis.
What interventions are being tested in trial NCT03021499?
The interventions under investigation include: Placebo Oral Capsule (DRUG), Voclosporin (DRUG).
Who is sponsoring clinical trial NCT03021499?
This trial is sponsored by Aurinia Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03021499 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lupus Nephritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03021499's enrollment target sits among peer trials
358 6th of 30 higher than 25 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis 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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