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

CSL Behring K.K.0 个研究点目标入组 2,190 人开始时间: 2024年10月17日最近更新: 2025年4月10日

试验速览

暂无简介。

•Male or female at least 18 years of age
•A diagnosis of end stage kidney disease (ESKD) undergoing maintenance dialysis for at least 12 weeks
•Serum hs-CRP >= 2.0 mg/L
•A diagnosis of diabetes mellitus OR atherosclerotic cardiovascular disease (ASCVD)

•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 liver function tests
•Any life-threatening disease expected to result in death within 12 months
•A history of gastrointestinal perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
•Clinically significant active infection or history of opportunistic or invasive fungal infection

Time to first occurrence of CV death or myocardial infaction (MI)

时间窗: approximately 5 years

Time to first occurrence of cardiovascular (CV) death or myocardial infarction (MI)

Time to first occurrence of CV death, MI, or ischemic stroke(approximately 5 years)
Time to first occurrence of CV death(approximately 5 years)
Total number of hospitalizations(approximately 5 years)
Time to first occurrence of all-cause death or MI(approximately 5 years)
Time to first occurrence of all-cause death(approximately 5 years)
Time to first occurrence of CV death, MI, or major adverse limb event(approximately 5 years)
Time to first occurrence of CV death, MI, or hospitalization for heart failure(approximately 5 years)
Total number of CV hospitalizations(approximately 5 years)
Total number of heart failure hospitalizations and urgent visits(approximately 5 years)

发起方