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 (AURinia Orelvo Renal Assessments) 2: Aurinia Renal Response in Lupus with Orelvo

Aurinia Pharmaceuticals, Inc.0 个研究点目标入组 324 人开始时间: 2018年4月13日最近更新: 2021年11月29日

研究概览

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•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 Protocol Section 5.4, Adequate/Effective Contraception).
•5.Subject is willing to continue taking oral MMF for the duration of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 310
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 14

•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 Protocol Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
•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 treatment.

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