CTIS2022-500273-14-00招募中1 期
A Phase 2b/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis - CSL300_2301
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,039
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
- •Male or female at least 18 years of age., A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks., Serum hs-CRP = 2.0 mg/L., A diagnosis of diabetes mellitus OR ASCVD.
排除标准
- •Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)., Concomitant use of systemic immunosuppressant drugs., Abnormal LFTs., Any life-threatening disease expected to result in death within 12 months., A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease.
研究者
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