Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)

What this study is about

This is a two-part, phase 2b and phase 3 combined 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 vs placebo 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Nephrology of North Alabama, Decatur, Alabama, United States
• Nephrology Consultants, LLC, Huntsville, Alabama, United States
• DaVita Clinical Research Montgomery, Montgomery, Alabama, United States
• AKDHC Medical, Glendale, Arizona, United States
• Kidney Disease Medical Group, Glendale, Arizona, United States
• AKDHC Medical, Phoenix, Arizona, United States
• AKDHC Medical, Tucson, Arizona, United States
• Southern Arizona VA Health Care System, Tucson, Arizona, United States
• National Institute of Clinical Research, Bakersfield, California, United States
• Amicis Research Center, Beverly Hills, California, United States
• California Institute of Renal Research, Chula Vista, California, United States
• The Medical Research Group, Inc., Fresno, California, United States

+ 535 more sites.

Who to contact

Trial Registration Coordinator · +1 610-878-4697 · clinicaltrials@cslbehring.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05485961.