Overview

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

Status:
Not yet recruiting
Trial end date:
2028-12-01
Target enrollment:
Participant gender:
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 CV outcomes and safety in subjects with end stage kidney disease (ESKD) undergoing maintenance dialysis with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
CSL Behring