Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)

Time frame: Week 12

Change from baseline in log-transformed hs-CRP (Phase 2b)

Time frame: Baseline and up to 24 weeks

Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in fibrinogen (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in albumin (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in Hepcidin (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in hemoglobin (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in iron (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)

Time frame: Baseline and up to 12 weeks

Mean change from Baseline in ferritin (Phase 2b)

Time frame: Baseline and up to 12 weeks

Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)

Time frame: Up to 24 weeks

Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)

Time frame: Up to 24 weeks

Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)

Time frame: Up to 24 weeks

Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)

Time frame: Up to 24 weeks

Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)

Time frame: Up to 32 weeks

Mean change from Baseline in white blood cell (WBC) (Phase 2b)

Time frame: Up to 12 weeks

Mean change from Baseline in neutrophils (Phase 2b)

Time frame: Up to 12 weeks

Mean change from Baseline in platelets (Phase 2b)

Time frame: Up to 12 weeks

Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)

Time frame: Up to 12 weeks

Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)

Time frame: Up to 12 weeks

Mean change from Baseline in total bilirubin (Phase 2b)

Time frame: Up to 12 weeks

Mean change from Baseline in lipid panel (Phase 2b)

Lipid panel consists of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride.

Time frame: Up to 12 weeks

Titer of confirmed antibodies specific to CSL300 (Phase 2b)

Time frame: Up to 12 weeks

Time to first occurrence of all-cause death or MI (Phase 3)

Time frame: Approximately 5 years

Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)

Time frame: Approximately 5 years

Time to first occurrence of CV death (Phase 3)

Time frame: Approximately 5 years

Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)

Time frame: Approximately 5 years

Time to first occurrence of all-cause death (Phase 3)

Time frame: Approximately 5 years

Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)

Time frame: Approximately 5 years

Total number of CV hospitalizations (Phase 3)

Time frame: Approximately 5 years

Total number of HF hospitalizations and urgent visits (Phase 3)

Time frame: Approximately 5 years

Total number of hospitalizations (Phase 3)

Time frame: Approximately 5 years