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Active (not recruiting) Phase 3 NCT05021835

ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

Phase 3 – large-scale trial before approval
Conditions: Cardiovascular Risk Chronic Kidney Disease Inflammation

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
This 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.
Who can participate
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).
Locations 36
Argentina (1)
Mautalen Salud e investigación
CABA , Buenos Aires
Australia (1)
Canberra Hospital
Garran , Australian Capital Territory
Belgium (1)
AZORG Aalst - Moorselbaan
Aalst
Brazil (1)
Centro de Diag. e Pesquisa da Osteoporose do Espírito Santo
Vitória , Espírito Santo
Bulgaria (1)
MC Diamedical - 2013 OOD, Dimitrovgrad
Dimitrovgrad
Canada (1)
LMC Clin Res Inc. Calgary
Calgary , Alberta
China (1)
Fu Yang People's Hospital-Nephrology
Fuyang , Anhui
Croatia (1)
KB Dubrava, Zavod za bolesti srca i krvnih zila
Zagreb , City of Zagreb
Czech Republic (1)
Edumed Broumov
Broumov
Denmark (1)
Holbæk Sygehus - Forskningsenheden, Medicinsk Afdeling, afs. 44-4
Holbæk , Region Sjælland
Greece (1)
University Hospital of Athens ATTIKON
Athens , Attica
Hungary (1)
Dr. Lakatos Ferenc Kardiológus ,Belgyógyász Magán szakrendelés
Békéscsaba , Bekes County
India (1)
Lalitha PVS Institute of Medical Sciences
Guntur , Andhra Pradesh
Israel (1)
Wolfson MC - Diabetes Clinic
Holon
Italy (1)
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro , Cz
Japan (1)
Uwajima City Hospital_ Cardiology
Uwajima-shi , Ehime
Latvia (1)
Ari Med
Daugavpils
Lithuania (1)
Klinikiniai sprendimai, Alytus
Alytus
Malaysia (1)
Hospital Sultanah Bahiyah
Alor Star , Kedah
Mexico (1)
CINCAME
Tijuana , Estado de Baja California
Netherlands (1)
Noordwest Ziekenhuisgroep
Alkmaar
Poland (1)
Kardio Life - Tomasz Borkowski
Włocławek , Kuyavian-Pomeranian Voivodeship
Romania (1)
Institutul Clinic Fundeni
Bucharest , Bucharest
Russia (1)
Reg. State Budget Healthc. Inst. Regional Clinical Hospital
Barnaul
Serbia (1)
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad , Vojvodina
Slovakia (1)
CARDIOCONSULT, s.r.o.
Bratislava
South Africa (1)
Excellentis Clinical Trial Consultants
George , Eastern Cape
South Korea (1)
National Health Insurance Corporation Ilsan Hospital
Goyang-si , Gyeonggi-do
Spain (1)
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid
Sweden (1)
Karolinska Universitetssjukhuset, Huddinge
Huddinge , Stockholm County
Taiwan (1)
HsinChu MacKay Memorial Hospital
Hsinchu
Thailand (1)
Siriraj Hospital
Bangkok Noi , Bangkok
Turkey (1)
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi Hastanesi- Nefroloji
Istanbul , Bakirkoy
Ukraine (1)
Chernivtsi Emergency Hospital - Therapeutic Department No.1
Chernivtsi
United Kingdom (1)
Ashfields Primary Care Centre
Sandbach , Cheshire
United States (1)
Uni of Alabama at Birmingham
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.08.2021
Completion date
09.06.2026
Registry ID
NCT05021835
Source
anzctr
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