POSIBIL_ESKD: Clazakizumab Cardiovascular Outcomes Study

Study Overview

A Phase 2b/3, multicenter, randomized, double-blind, placebo-controlled study evaluating CSL300 (clazakizumab), an anti-interleukin-6 (IL-6) monoclonal antibody, for reducing cardiovascular events in subjects with end stage kidney disease (ESKD) undergoing maintenance dialysis. The primary endpoint is time to first occurrence of cardiovascular death or myocardial infarction. Clazakizumab targets chronic inflammation, a key driver of cardiovascular risk in dialysis patients.

Inclusion Criteria

• ✓Adults aged 18 years or older
• ✓Diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
• ✓Serum hs-CRP ≥2.0 mg/L (evidence of systemic inflammation)
• ✓Diagnosis of diabetes mellitus OR atherosclerotic cardiovascular disease (ASCVD)
• ✓ASCVD evidenced by history of CAD, MI, PCI, CABG, or peripheral artery disease

Exclusion Criteria

• ✗Concomitant systemic immunosuppressant agents
• ✗Primary immunodeficiency
• ✗Positive tuberculosis test or HIV/HBV/HCV infection
• ✗Active clinically significant infection requiring antimicrobial therapy
• ✗Recent MI, PCI, or CABG within 90 days
• ✗Decompensated heart failure (NYHA Class III/IV)
• ✗Life-threatening disease expected to cause death within 12 months
• ✗Neutropenia (ANC <2000/mm³) or thrombocytopenia (platelets <100,000/mm³)