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

Summary

This is a 2-part (phase 2b/3) 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 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.

Eligibility

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

Conditions5

Locations163 sites

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