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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3).
• Concomitant use of systemic immunosuppressant drugs.
• Abnormal LFTs.
• Any life-threatening disease expected to result in death within 12 months.
• A history of GI perforation, inflammatory bowel disease (except fully excised. ulcerative colitis), or peptic ulcer disease.
• Clinically significant active infection or history of opportunistic or invasive fungal infection.

CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.