Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing 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 inPart 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 excisedulcerative colitis), or peptic ulcer disease

• Clinically significant active infection or history of opportunistic or invasivefungal infection