What is the Purpose of this Study?
The purpose of this study is to determine whether a drug called CSL300 (clazakizumab) is effective and safe in patients on maintenance dialysis for reducing the risk of death from a heart attack or heart-related events. Only patients with systemic inflammation AND either atherosclerotic cardiovascular disease or diabetes mellitus are eligible for the study. CSL300 is a monoclonal antibody, which is a protein made in a lab that binds and blocks specific substances. CSL300 is designed to block a protein called interleukin 6 (IL-6). IL-6 is important in inflammation and may be involved in the development of negative heart-related events in patients undergoing maintenance dialysis. Participants will be randomly assigned to receive either CSL300 or placebo (inactive substance).
Eligibility
- * 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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 2b / 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 in Subjects with End Stage Kidney Disease Undergoing Dialysis