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

Recruiting Phase 2 Phase 3 Interventional Study
End Stage Kidney Disease
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About This Trial
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 di…
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Eligibility Criteria
Inclusion 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. Exclusion Criteria: * Subjects who participated in Part 1 (phase 2b) are not eligible…
Contacts

Trial Registration Coordinator

+1 610-878-4697

clinicaltrials@cslbehring.com

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