Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammatio

Phase 3

Recruiting

• Conditions: systemische ontstekingen; Atherosclerotic cardiovascular disease and chronic kidney disease; 10082206; 10038430

• Registration Number: NL-OMON54148
• Lead Sponsor: ovo Nordisk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

•Chronic kidney disease defined by one of the below:
eGFR >=15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) creatinine equation) or UACR >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) <= 0.90 at rest
ii. Intermittent claudication with a >=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
•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
• Study Design: Not specified