CTRI/2023/12/060561招募中2 期
A Phase 2b, Randomized, Controlled Double-blind,Multicenter Study Comparing the Efficacy and Safety ofZetomipzomib (KZR-616) 30 mg or 60 mg with Placeboin Patients with Active Lupus Nephritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 279
- 试验地点
- 19
- 主要终点
- The primary efficacy endpoint is the proportion of patients achieving complete renal response (CRR) at Week 37
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Body mass index of ≥ 18 kg/m2 (m square) eGFR ≥ 30 mL/min/1.73 m2 (m square) -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
- •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
- •weeks prior to Screening 3)Positive test at Screening for HIV, hepatitis B/C 4) Known intolerance to MMF or equivalent and corticosteroids.
结局指标
主要结局
The primary efficacy endpoint is the proportion of patients achieving complete renal response (CRR) at Week 37
时间窗: 37 Weeks
次要结局
- Partial Renal Response (PRR)(Complete Renal Response (CRR))
研究者
研究点 (19)
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