Aurinia Renal Assessments 2: Aurinia Renal Response in Lupus With Voclosporin

• Status: Completed
• Trial end date: 2021-10-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurinia Pharmaceuticals Inc.
• Treatments: Calcineurin Inhibitors; Cyclosporine

Criteria

Inclusion Criteria:

1. 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.

2. Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12.

3. Subject is willing to continue taking oral MMF for the duration of the study.

Exclusion Criteria:

1. 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.

2. Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.

3. A planned kidney transplant within study treatment period.

4. 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.

5. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.

6. Vaccines using live organisms, virus or bacterial, while taking the study treatment.