A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis - VOCA

Aurinia Pharmaceuticals Inc.0 个研究点目标入组 40 人开始时间: 2022年1月18日最近更新: 2022年4月19日

研究概览

暂无简介。

•1. Male or female subjects 12 to <18 years of age at the time of screening
•2. Previous diagnosis of SLE according to the 2019 EULAR/ACR classification criteria.
•3. Subjects with kidney biopsy result, with evidence of active nephritis
•Refer to protocol for full list of inclusion criteria
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Estimated glomerular filtration rate of <60 mL/min/1.73 m2 at screening confirmed before randomization
•2. Use of immunosuppression biologic agents within 12 weeks prior to randomization
•3. Use of cyclophosphamide, cholestyramine, calcineurin inhibitors, live attenuated vaccines and initiation or dose changes in ARBs and ACEi within 4 weeks prior to randomisation
•4. Use of Strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization
•5. Currently requiring renal dialysis or expected to require dialysis during the study period
•6. A previous kidney transplant or planned transplant within study treatment period.
•7. 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.
•8. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions
•Refer to protocol for full list of exclusion criteria

发起方