Status: Recruiting
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
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.
Participants needed: 3,110
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: CSL BehringUpdated: Jun 8, 2026Locations: 547
Eligibility criteria
Male or female at least 18 years of age. [+3]
Subjects who participated in Part 1 (phase 2b) are not eligible to participate i... [+5]