A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis

Kezar Life Sciences, Inc.0 个研究点目标入组 0 人开始时间: 2024年4月18日最近更新: 2024年8月20日

适应症

试验速览

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•1.Is able to provide written informed consent before any study-related procedures are performed.
•2.Is aged =18 years at the time of signing the informed consent.
•3.Has a body mass index of =18 kg/m2.
•4.eGFR =30 mL/min/1.73 m^2
•5.Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test
•6.Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening.
•7.UPCR =1.0 (Class III/IV +/-V) or UPCR =2.0 (Class V)
•8.Adequate hematologic, hepatic, and renal function

•1.Current or medical history of:
•Central nervous system manifestations of SLE
•Overlapping autoimmune condition that may affect study assessments/outcomes
•Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
•Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions
•Solid organ transplant or planned transplant during study
•Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers >5 years ago
•2.Has received dialysis within the 52 weeks prior to Screening
•3.Positive test at Screening for HIV, hepatitis B/C Known intolerance to MMF or equivalent and corticosteroids

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