CTIS2022-502227-22-00招募中1 期
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 - KZR-616-202
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 247
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 65+（—）
- 性别
- All
入选标准
- •Body mass index of =18 kg/m^2 eGFR =30 mL/min/1.73 m^2 Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening. UPCR =1.0 (Class III/IV +/-V) or UPCR =2.0 (Class V) Adequate hematologic, hepatic, and renal function
排除标准
- •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 4. Known intolerance to MMF or equivalent and corticosteroids
研究者
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