2023-506926-35-00已完成3 期
ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,335
- 试验地点
- 250
- 主要终点
- Time to first occurrence of 3-point MACE, a composite endpoint consisting of CV death, non-fatal MI, and non-fatal stroke. Measured from randomisation to end-of-study.
研究概览
简要总结
To demonstrate the superiority of ziltivekimab CCI s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established ASCVD, CKD and systemic inflammation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease defined by one of the below: eGFR ≥15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation), OR UACR ≥200 mg/g and eGFR ≥60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation).
- •Serum hs-CRP ≥2 mg/L
- •Evidence of ASCVD by one or more of the following: Coronary heart disease defined as at least one of the following: Documented history of MI, prior coronary revascularisation procedure, or ≥50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography. Cerebrovascular disease defined as at least one of the following: Prior stroke of atherosclerotic origin, prior carotid artery revascularisation procedure, or ≥50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound. Symptomatic peripheral artery disease (PAD) defined as at least one of the following: Intermittent claudication with an ankle-brachial index (ABI) ≤ 0.90 at rest, intermittent claudication with a ≥50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound, prior peripheral artery (excluding carotid) revascularisation procedure, or lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis).
排除标准
- •Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
- •Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2).
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of randomisation (visit 2).
- •Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
研究组 & 干预措施
ziltivekimab
Test
干预措施: ziltivekimab (Drug)
Placebo (ziltivekimab)
Placebo
干预措施: Placebo (ziltivekimab) (Drug)
结局指标
主要结局
Time to first occurrence of 3-point MACE, a composite endpoint consisting of CV death, non-fatal MI, and non-fatal stroke. Measured from randomisation to end-of-study.
Time to first occurrence of 3-point MACE, a composite endpoint consisting of CV death, non-fatal MI, and non-fatal stroke. Measured from randomisation to end-of-study.
次要结局
- Change in UACR from randomisation to 2 years.
- Change in eGFR (CKD-EPI) from randomisation to 2 years.
- Annual rate of change in eGFR (CKD-EPI) (total eGFR slope) from randomisation to end-of-study.
- Change in hs-CRP from randomisation to 2 years.
- Change in NT-pro-BNP from randomisation to 2 years.
- Change in left ventricular ejection fraction (LVEF) from randomisation to 2 years.
- Number of events of atrial fibrillation from randomisation to end-of-study.
- Change in haemoglobin from randomisation to 2 years.
- Time to first occurrence of expanded MACE, a composite endpoint consisting of CV death, non-fatal MI, non-fatal stroke, and hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation. Measured from randomisation to end-of-study.
- Number of heart failure hospitalisations or urgent heart failure visits or CV deaths from randomisation to end-of-study.
- Time to first occurrence of a composite kidney endpoint consisting of CV death, onset of persistent ≥ 40% reduction in eGFR (CKD-EPI) compared with baseline and kidney failure defined as death from kidney failure, onset of persistent eGFR< 15 mL/min/1.73 m2 (CKD-EPI), or initiation of chronic kidney replacement therapy. Measured from randomisation to end-of-study.
- Time to occurrence of all-cause mortality from randomisation to end-of-study.
- Time to first occurrence of each of the individual components of the expanded MACE endpoint and the kidney composite endpoint from randomisation to end-of-study.
- Time to first occurrence of MIs (fatal and non-fatal) from randomisation to end-of-study.
- Time to first occurrence of stroke (fatal and non-fatal) from randomisation to end-of-study.
- Time to first occurrence of a composite MACE endpoint consisting of all-cause mortality, non-fatal MI, and non-fatal stroke. Measured from randomisation to end-of-study.
- Time to first occurrence of a 4-component kidney endpoint consisting of onset of persistent ≥ 40% reduction in eGFR (CKD-EPI) compared with baseline, and kidney failure defined as death from kidney failure, onset of persistent eGFR< 15 mL/min/1.73 m2 (CKD-EPI), or initiation of chronic kidney replacement therapy. Measured from randomisation to end-of-study.
- Time to first occurrence of coronary revascularisation from randomisation to end-of-study.
- Number of hospitalisations with infection as primary cause or death due to infection from randomisation to end-of-study.
- Change in Short Form 36 (SF-36) Physical Component Score (PCS) from randomisation to 2 years.
研究者
EU submission Hub
Scientific
Novo Nordisk A/S
研究点 (250)
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