This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study.
Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.
Male or female at least 18 years of age.
A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks.
Serum hs-CRP ≥ 2.0 mg/L.
A diagnosis of diabetes mellitus OR ASCVD.
Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3).
Concomitant use of systemic immunosuppressant drugs.
Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.
Abnormal LFTs.
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Treatment groupsSee each treatment group below.