ZEUS – A research study to look at how ziltivekimab works compared to placebo in people with cardiovascular disease, chronic kidney disease and inflammatio

Phase 1

• Conditions: Atherosclerotic cardiovascular diseaseChronic kidney disease Systemic inflammation; MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866; MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.1Level: LLTClassification code 10067394Term: hs-CRP increasedSystem Organ Class: 100000004848; MedDRA version: 21.0Level: LLTClassification code 10011418Term: CRP increasedSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-004853-59-PL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-24
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6200

Inclusion Criteria

-Chronic kidney disease defined by one of the below:
- 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)
- UACR above or equal to 200 mg/g and eGFR above or equal to 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation).
- Serum hs-CRP greater than or equal to 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.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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4950

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified