CTRI/2021/10/037463招募中3 期
ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes inparticipants with established atherosclerotic cardiovascular disease, chronickidney disease and systemic inflammation - ZEUS
ovo Nordisk AS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
- •Disease specific
- •3. eGFR =15 and < 60 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology
- •Collaboration (CKD-EPI) creatinine equation).a
- •4. Serum hs-CRP =2 mg/L at screening (visit 1).
- •5. 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).
- •a Laboratory results of eGFR for inclusion can be based on:
- •measurements no more than 90 days old at screening, documented in medical records or
- •measurements obtained the optional pre-screening visit (see Section 8.1), documented in
- •medical records or
- •central laboratory measurement obtained at the screening visit (visit 1).24, 25
- •The subject must have been/be in usual health condition at the time of sample collection used for inclusion as evaluated by the investigator. See Appendix 2 for all requirements regarding clinical laboratory tests including requirements to creatinine assays and eGFR equations.
排除标准
- •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 investigator’s opinion might jeopardise participant’s safety or
- •compliance with the protocol.
- •6. Inadequate standard of care treatment which in the investigator’s opinion makes the
- •participant’s participation in the study inappropriate.
- •Laboratory values
- •7. Absolute neutrophil count <2×109/L at screening (visit 1).
- •8. Platelet count <120×109/L at screening (visit 1).
- •9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × upper limit of
- •normal at screening (visit 1).
- •10. HbA1c = 10% (= 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) at screening (visit 1).
- •13. Current (or within 90 days of visit 1) chronic or intermittent haemodialysis or peritoneal
- •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) 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 pressure >180 mmHg or an
- •average diastolic blood pressure >110 mmHg) at screening (visit 1). (Note: Potential
- •participants may be retested for this criterion within the visit window and without rescreening, <br
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