A Research Study of How the Medicine Ziltivekimab Works in the Body of Chinese Men and Women With Kidney Disease and Inflammation

Korábbi kezelés

• History of gastrointestinal perforation. (Note: History of perforated appendicitis more than 5 years prior to screening (visit 1) is not exclusionary).
• History of active diverticulitis in the 5 years prior to randomization (visit 2).
• History of inflammatory bowel disease that has been clinically active during the 12 months prior to randomization (visit 2).
• Myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 60 days prior to randomization (visit 2).
• Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomization (visit 2) or any major surgical procedure planned at the time of randomization (visit 2). Prior or current medication
• Use of preventive systemic antibiotics, systemic antivirals, or systemic antifungals at screening (visit 1). (Note: "Systemic" is defined as oral or intravenous (i.v.) administered drugs that are absorbed into the circulation).

Más betegség

• Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
• Use of systemic immunosuppressive drugs (both small molecules and biologics) or biologic disease modifying anti-rheumatic drugs (DMARDs including both biologic DMARDs like anti-TNF-alpha and conventional DMARDs like methotrexate) at screening (visit 1) or anticipated chronic use of such drugs any time during the study. (Note: Use of otic, ophthalmic, inhaled, and topical corticosteroids or local corticosteroid injections are not exclusionary).

Laborértékek

• Laboratory values
• Absolute neutrophil count less than 2×10\^9/Litre at screening (visit 1).
• Platelet count less than 120×10\^9/Litre at screening (visit 1).
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 × upper limit of normal at screening (visit 1).
  • Medical conditions

Egyéb

• Planned coronary, carotid or peripheral artery revascularization known on the day of screening (visit 1).

• Estimated glomerular filtration rate (eGFR) greater than or equal 15 and less than 60 mL/min/1.73 m\^2 [Millilitre/minute] (using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation)
• Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 mg/L [Milligram Per Litre] at screening (visit 1).