Clinical Trial

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

Study acronym: POSIBIL6ESKD
Recruiting Phase 2/3
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Summary
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.
Protocol Amendment History 7 changes
notable Trial sites expanded: 548 -> 557 locations 2026-08-12
notable Trial sites expanded: 542 -> 547 locations 2026-06-09
notable Enrollment increased: 2310 -> 3110 participants 2026-06-03
notable Trial sites expanded: 538 -> 542 locations 2026-05-02
notable Primary completion moved earlier: 2029-09-27 -> 2029-05-22 2026-05-02
minor Completion moved earlier: 2029-09-27 -> 2029-05-22 2026-05-02
notable Trial sites expanded: 468 -> 538 locations 2026-04-10
Trial Details
NCT Number NCT05485961
Lead Sponsor CSL Behring
Conditions End Stage Kidney Disease
Enrollment 3,110 participants
Start Date 2022-10-21
Primary Completion 2029-05-22 (estimated)
Study Completion 2029-05-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-11