- Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis — Recruiting • Phase II / Phase III • Diabetes / Metabolic • NCT05485961.
- A trial testing clazakizumab (an anti-inflammatory drug) to reduce heart disease and death in dialysis patients with inflammation.
- Word count: 18 words.
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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. Conditions: Atherosclerotic Cardiovascular Disease, End Stage Kidney Disease, Atherosclerotic Cardiovascular Disease in Patients With ESKD Interventions: CSL300, Placebo Lead Sponsor: CSL Behring Planned Enrollment: 2310 participants