NL-OMON50319已完成3 期
A Randomized, Controlled, Double-blind Continuation Study Comparing the Long*term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis - AURORA 2: Aurinia Renal Response in Lupus with Orelvo
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent before any study-specific procedures are performed.
- •2. Male or female 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.
- •3. In the opinion of the Investigator, subject requires continued
- •immunosuppressive therapy.
- •4. Women of childbearing potential must continue to use effective contraception
- •and have a negative urine pregnancy test at Month 12. Two effective forms of
- •contraception must be used simultaneously unless abstinence is the chosen
- •method. Subjects must use effective contraception during the study (see
- •Section5.4, Adequate/Effective Contraception).
- •5. Subject is willing to continue taking oral MMF for the duration of the
排除标准
- •1. Subjects unable or unwilling to give written informed consent and/or to
- •comply with study procedures.
- •2. 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
- •3. Subjects currently requiring renal dialysis (hemodialysis or peritoneal
- •dialysis) or expected to require dialysis during the study period.
- •4. A planned kidney transplant within study treatment period.
- •5. 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.
- •6. Subjects who are pregnant, breast feeding or, if of childbearing potential,
- •not using adequate contraceptive precautions.
- •7. Vaccines using live organisms, virus or bacterial, while taking the study
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