Skip to main content

Atherosclerotic Cardiovascular Disease

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
NCT05485961 | Phase 2 | Interventional

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 ASCVD or diabetes mellitus and evidence of systemic inflammation who are undergoing maintenance dialysis.

Trial Information
1 Sites
2310 Participants
18 Years

If interested, contact for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Peninsula Kidney Associates
Hampton,Virginia,United States,23666

Study Eligibility 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
  • 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

Additional Studies

Additional studies can be found at