ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
Chronic Kidney Disease | Inflammation | Cardiovascular RiskThis study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation.
Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same.
Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe.
Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly.
The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits.
Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram).
Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* Chronic kidney disease defined by one of the below:
1. Estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 15 and below 60 mL/min/1.73 m\^2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
2. Urinary albumin-to-creatinine ratio (UACR) \>= 200 milligrams per gram (mg/g) and eGFR \>= 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation)
* Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligram per liter (mg/L)
* Evidence of atherosclerotic cardiovascular disease (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. greater than or equal to 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. greater than or equal to 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) below or equal to 0.90 at rest ii. Intermittent claudication with a greater than or equal to 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:
* 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).
Study Location
LMC Clin Res Inc. Calgary
LMC Clin Res Inc. CalgaryCalgary, Alberta
Canada
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BC Diabetes Canada
BC Diabetes CanadaVancouver, British Columbia
Canada
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Cambridge Cardiac Care Centre
Cambridge Cardiac Care CentreCambridge, Ontario
Canada
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One Heart Care
One Heart CareMississauga, Ontario
Canada
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Oakville Cardiovascular Research LP
Oakville Cardiovascular Research LPOakville, Ontario
Canada
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LMC Endo Centres Ltd.(Bayview)
LMC Endo Centres Ltd.(Bayview)Toronto, Ontario
Canada
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Ctr de rech Clin de Laval
Ctr de rech Clin de LavalLaval, Quebec
Canada
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LMC ClinRsrh Inc.Brampton
LMC ClinRsrh Inc.BramptonBrampton, Ontario
Canada
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Premier Clinical Trial Research Network (PCTRN)
Premier Clinical Trial Research Network (PCTRN)Hamilton, Ontario
Canada
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North York Diagn & Cardiac Ctr
North York Diagn & Cardiac CtrNorth York, Ontario
Canada
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Heart Health Institute Research, Inc.
Heart Health Institute Research, Inc.Scarborough, Ontario
Canada
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Viacar Recherche Clinique Inc.
Viacar Recherche Clinique Inc.Brossard, Quebec
Canada
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C-endo Diab Endo Clin Calgery
C-endo Diab Endo Clin CalgeryCalgary, Alberta
Canada
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Nova Scotia Hlth Halifax
Nova Scotia Hlth HalifaxHalifax, Nova Scotia
Canada
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LMC Clin Res Inc. Thornhill
LMC Clin Res Inc. ThornhillConcord, Ontario
Canada
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LMC Clinical Research Inc. Oakville
LMC Clinical Research Inc. OakvilleOakville, Ontario
Canada
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LMC Research Inc. Ottawa
LMC Research Inc. OttawaNepean, Ontario
Canada
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Diabetes Heart Research Centre
Diabetes Heart Research CentreToronto, Ontario
Canada
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Centre de recherché du CHUS
Centre de recherché du CHUSSherbrooke, Quebec
Canada
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LMC Diabetes & Endocrinology (Barrie)
LMC Diabetes & Endocrinology (Barrie)Barrie, Ontario
Canada
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Synergy Wellness Clinic
Synergy Wellness ClinicSherwood Park, Alberta
Canada
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Partnrs Adv Cardio Eval (PACE)
Partnrs Adv Cardio Eval (PACE)Newmarket, Ontario
Canada
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Centricity Research Etobicoke
Centricity Research EtobicokeEtobicoke, Ontario
Canada
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Clinical Research Solutions Inc.
Clinical Research Solutions Inc.Waterloo, Ontario
Canada
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Kawartha Cardiology Clinical Trials
Kawartha Cardiology Clinical TrialsPeterborough, Ontario
Canada
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Centre de santé et de services
Centre de santé et de servicesTerrebonne, Quebec
Canada
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- Study Sponsored By
- Novo Nordisk A/S
- Participants Required
- More Information
- Study ID:
NCT05021835