Last updated 3 months ago
ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation
6200 patients around the world
Available in Argentina, Mexico, United States, Brazil, Spain
Novo Nordisk A/S
21Research sites
6200Patients around the world
This study is for people with
Cardiovascular disease
Renal disease
Chronic kidney disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Chronic kidney disease defined by one of the below.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).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.Coronary heart disease defined as at least one of the following.Documented history of MI.Prior coronary revascularisation procedure.Greater than or equal to 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.Greater than or equal to 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) below or equal to 0.90 at rest.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.Prior peripheral artery (excluding carotid) revascularisation procedure.Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis).
- 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).
Sites
CER Instituto Médico - Quilmes, Buenos Aires
Recruiting
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas San Nicolás
Recruiting
ICBA Instituto Cardiovascular de Buenos Aires
Recruiting
Centro Especialidades Médicas SRL (CEMEDIC)
Recruiting
Investigación Clínica Aplicada S.R.L.
Recruiting
Centro Médico Lebensohn
Recruiting
Hospital Italiano de La Plata
Recruiting
Centro de Investigación Cardiometabólica de Aguascalientes, S.C.
Recruiting
FAICIC Clinical Research
Recruiting
StudyZEUS
SponsorNovo Nordisk A/S
Study typeInterventional
Conditions
Cardiovascular diseaseChronic kidney disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05021835
