NCT05485961招募中2 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- CSL Behring
- 入组人数
- 3,110
- 试验地点
- 565
- 主要终点
- Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
研究概览
简要总结
This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study.
Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.
- •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.
- •Clinically significant active infection or history of opportunistic or invasive fungal infection.
研究组 & 干预措施
Placebo (Phase 2b)
Placebo Comparator
IV administration
干预措施: Placebo (Drug)
Placebo (Phase 3)
Placebo Comparator
IV administration
干预措施: Placebo (Drug)
CSL300 (high dose)(Phase 2b)
Experimental
IV administration
干预措施: CSL300 (Drug)
CSL300 (Phase 3)
Experimental
IV administration
干预措施: CSL300 (Drug)
CSL300 (medium dose)(Phase 2b)
Experimental
IV administration
干预措施: CSL300 (Drug)
CSL300 (low dose)(Phase 2b)
Experimental
Intravenous (IV) administration
干预措施: CSL300 (Drug)
结局指标
主要结局
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
时间窗: Baseline and up to Week 12
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
时间窗: Approximately 5 years
次要结局
- Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)(Up to Week 32)
- Mean change from Baseline in white blood cell (WBC) (Phase 2b)(Up to Week 12)
- Mean change from Baseline in neutrophils (Phase 2b)(Up to Week 12)
- Mean change from Baseline in platelets (Phase 2b)(Up to Week 12)
- Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)(Up to Week 12)
- Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)(Up to Week 12)
- Mean change from Baseline in total bilirubin (Phase 2b)(Up to Week 12)
- Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in albumin (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in Hepcidin (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in hemoglobin (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in iron (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in ferritin (Phase 2b)(Baseline and up to Week 12)
- Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)(Up to Week 24)
- Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)(Up to Week 24)
- Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)(Up to Week 24)
- Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)(Up to Week 24)
- Change from baseline in log-transformed hs-CRP (Phase 2b)(Baseline and up to Week 24)
- Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in fibrinogen (Phase 2b)(Baseline and up to Week 12)
- Mean change from Baseline in lipid panel (Phase 2b)(Up to Week 12)
- Titer of confirmed antibodies specific to CSL300 (Phase 2b)(Up to Week 12)
- Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)(Up to 5 years)
- Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)(Week 12)
- Time to first occurrence of all-cause death or MI (Phase 3)(Approximately 5 years)
- Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)(Approximately 5 years)
- Time to first occurrence of CV death (Phase 3)(Approximately 5 years)
- Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)(Approximately 5 years)
- Time to first occurrence of all-cause death (Phase 3)(Approximately 5 years)
- Total number of CV hospitalizations (Phase 3)(Approximately 5 years)
- Total number of HF hospitalizations and urgent visits (Phase 3)(Approximately 5 years)
- Total number of hospitalizations (Phase 3)(Approximately 5 years)
研究者
研究点 (565)
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