AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Aurinia Pharmaceuticals Inc.
- Study ID
- NCT02141672
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Voclosporin High Dose — DRUG
- Voclosporin Low Dose — DRUG
- Placebo — DRUG
Study Details
To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.
Key Dates
- Start date
- Jun 30, 2014
- Status verified
- Apr 2021
- Primary completion
- Jul 31, 2016
- Completion
- Jan 31, 2017
Study Design
- Enrollment
- 265 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Voclosporin Low DoseVoclosporin, oral, 23.7 mg BID
- Experimental: Voclosporin High DoseVoclosporin, oral 23.7 mg BID until Week 2, then voclosporin, oral, 39.5 mg BID
- Placebo Comparator: PlaceboLow dose: Voclosporin placebo, oral, 3 capsules BID High dose: Voclosporin placebo, oral, 3 capsules BID until Week 2 then voclosporin placebo, oral, 5 capsules BID
Primary Outcome Measure
Number of Subjects Achieving Complete Renal Remission at 24 Weeks [ Time Frame: week 24 ]
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AURA-LV Site | Los Angeles | California | 90095 | - |
| AURA-LV Site | Palo Alto | California | 94305 | - |
| AURA-LV Site | Gainesville | Florida | 32610 | - |
| AURA-LV Site | Miami | Florida | 33165 | - |
| AURA-LV Site | Farmington Hills | Michigan | 48334 | - |
| AURA-LV Site | Brooklyn | New York | 11203 | - |
| AURA-LV Site | New York | New York | 10016 | - |
| AURA-LV Site | Chapel Hill | North Carolina | 27599 | - |
| AURA-LV Site | Charlotte | North Carolina | 28204 | - |
| AURA-LV Site | Columbus | Ohio | 43210 | - |
| AURA-LV Site | Hershey | Pennsylvania | 17033 | - |
| AURA-LV Site | Chattanooga | Tennessee | 37408 | - |
| AURA-LV Site | Dallas | Texas | 75390 | - |
| AURA-LV Site | Houston | Texas | 77030 | - |
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