Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin
Completed · Phase 3 · Has a placebo group
Conditions studied: Lupus Nephritis
In brief
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).
Key facts
- Study ID
- NCT03597464
- Run by
- Aurinia Pharmaceuticals Inc.
- People needed
- 216
- Starts
- 2019-09-29
- Expected to finish
- 2021-10-07
- Last updated by the study team
- 2022-12-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
- Written informed consent before any study-specific procedures were performed.
- In the opinion of the investigator, subject required continued immunosuppressive therapy.
- Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.
- Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study.
You may not qualify if…
- Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
- Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- A planned kidney transplant within study treatment period.
- Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
- Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
- Vaccines using live organisms, virus or bacterial, while taking the study treatment.
Where it is running
- AURORA Investigative Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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