Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: Ziltivekimab: Ziltivekimab B 15 mg/mL
Dosage form: Solution for injection
Route of administration: Subcutaneous injection
Dose: 15 mg
Dosing instructions: Once-monthly
Duration of t
Sponsors
Novo Nordisk
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study, except for protocol described pre-screening activities which require a separate informed consent. 2. Age above or equal to 18 years at the time of signing informed consent. 3. Chronic kidney disease defined by one of the below: eGFR â?¥ 15 and Collaboration (CKD-EPI) creatinine equation)a UACR â?¥ 200 mg/g and eGFR â?¥ 60 mL/min/1.73 m2 (using the CKD-EPI creatinine equation).a 4. Serum hs-CRP â?¥ 2 mg/L.a 5. Evidence of ASCVD by one or more of the following: a) Coronary heart disease defined as at least one of the following: 1. Documented history of MI. 2. Prior coronary revascularisation procedure. 3. â?¥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: 1. Prior stroke of atherosclerotic origin. 2. Prior carotid artery revascularisation procedure. 3. â?¥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: 1. Intermittent claudication with an ankle-brachial index (ABI) â?¤ 0.90 at rest. 2. Intermittent claudication with a â?¥50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound. 3. Prior peripheral artery (excluding carotid) revascularisation procedure. 4. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis). a Laboratory results of eGFR3-5, UACR and hs-CRP for inclusion can be based on: measurements no more than 90 days old at screening, documented in medical records or measurements obtained at the optional pre-screening visit (see Section 8.1), documented in medical records or central laboratory measurement of eGFR, UACR or hs-CRP obtained at the screening visit (visit 1) or measurements from the prevalence study (NN6018-7527, FPFV expected Sep-2023) if nomore than 90 days old at screening.
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to study intervention (s) or related products. 2. Previous participation in this study. Participation is defined as randomisation. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method (adequate contraceptive measures as required by local regulation or practice). 4. Participation (i.e., signed informed consent) in any interventional clinical study of an approved or non-approved investigational medicinal product within 30 days prior to screening (visit 1). 5. Any disorder, which in the investigatorâ??s opinion might jeopardise participantâ??s safety or compliance with the protocol. 6. Inadequate standard of care treatment which in the investigatorâ??s opinion makes the participantâ??s participation in the study inappropriate. Laboratory values 7. Absolute neutrophil count 8. Platelet count 9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 Ã? upper limit of normal at screening (visit 1). 10. HbA1c â?¥ 10% (â?¥ 86 mmol/mol)a Medical conditions 11. Diagnosis of human immunodeficiency virus (HIV) and not receiving a stable antiretroviral regimen, at the discretion of the investigator at screening (visit 1). (Note: for Argentina, see country specific requirements (Appendix 8, Section 10.8)). 12. Active hepatitis C (positive anti-HCV and detectable HCV RNA) or hepatitis B (positive HBsAg and/or positive anti-HBc with detectable HBV DNA) at screening (visit 1). (Note: participants with positive anti-HBc and undetectable HBV DNA can be enrolled, see Section 8.3.7 for details). 13. Current (or within 90 days of visit 1) chronic or intermittent haemodialysis or peritoneal dialysis. 14. Clinical evidence of, or suspicion of, active infection at the discretion of the investigator. 15. History of recurrent serious infections (infections leading to hospitalisation or use of i.v. antibiotics, i.v. antiviral or i.v. antifungal treatment) in the 12 months prior to randomisation, at the discretion of the investigator. 16. History or evidence of untreated latent tuberculosis (TB) such as (but not limited to): History of a positive TB test or chest X-ray compatible with latent TB; and TB treatment initiated less than 28 days prior to randomisation. Confirmed positive for latent TB at optional pre-screening visit or screening (visit 1) (see details in Section 8.3.6) and TB treatment initiated less than 28 days prior to randomisation. 17. History of gastrointestinal perforation. (Note: History of perforated appendicitis more than 5 years prior to screening (visit 1) is not exclusionary). 18. History of active diverticulitis in the 5 years prior to randomisation (visit 2). 19. History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomisation (visit 2). 20. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris, or transient ischaemic attack within 60 days prior to randomisation (visit 2). 21. Uncontrolled hypertension (defined as an average systolic blood press
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of 3-point MACE, a composite endpoint consisting of: â?¢ CV death â?¢ non-fatal MI â?¢ non-fatal strokeTimepoint: From randomisation (month 0) to end-of-study (up to 63 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of expanded MACE, a composite endpoint consisting of: â?¢ CV deatha â?¢ non-fatal MI â?¢ non-fatal stroke â?¢ hospitalisation for unstable angina pectoris requiring urgent coronary revascularisation Timepoint: From randomisation (month 0) to end-of-study (up to 63 months) | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Denmark, Germany, Greece, India, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Republic of Korea, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactVijay Parthasarathy
Novo Nordisk India Pvt Ltd
Outcome results
None listed