systemische ontstekingen Atherosclerotic cardiovascular disease and chronic kidney disease
Conditions
Interventions
Oncemonthly ziltivekimab/placebo subcutaneous injection, single-use pre-filled
syringe (1 mL) or pen-injector (0.5 mL).
Sponsors
Novo Nordisk
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •Chronic kidney disease defined by one of the below: eGFR >=15 and 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: a) Coronary heart disease defined as at least one of the following: i. Documented history of MI ii. Prior coronary revascularisation procedure iii. >=50% stenosis in major epicardial coronary artery documented by cardiac catheterisation or CT coronary angiography b) Cerebrovascular disease defined as at least one of the following: i. Prior stroke of atherosclerotic origin ii. Prior carotid artery revascularisation procedure iii. >=50% stenosis in carotid artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound. c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following: i. Intermittent claudication with an ankle-brachial index (ABI) =50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound iii. Prior peripheral artery (excluding carotid) revascularisation procedure iv. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).
Exclusion criteria
Exclusion criteria: •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 •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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is time from randomisation to first occurrence of a major adverse cardiovascular event, a composite endpoint consisting of: cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| The confirmatory secondary endpoints are: • Time from randomisation to first occurrence of an expanded MACE endpoint consisting of: CV death, non-fatal MI, non-fatal stroke, or hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation • Number of hospitalisations for heart failure or urgent heart failure visit • Time to occurrence of all-cause mortality • Time to first occurrence of a composite CKD endpoint consisting of: onset of persistent >= 40% reduction in estimated glomerular filtration rate (eGFR)(CKD-EPI) compared with baseline, kidney failure defined as kidney death, onset of persistent eGFR (CKD-EPI) | — |
Countries
Netherlands
Outcome results
None listed