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

A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

Who can join

Ages 18 and older · All sexes

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 to participate in Part 2 (phase 3).
* Concomitant use of systemic immunosuppressant drugs.
* Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.
* 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.

About the study

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.

What is being tested

• CSL300 (drug)
• Placebo (drug)

Sponsor: CSL Behring · Participants: 3,110 · Started: Apr 27, 2024

Contact the study team

• Trial Registration Coordinator · Phone: +1 610-878-4697

Official record on ClinicalTrials.gov — NCT05485961

Locations in the U.S.

Conditions

• Kidney Failure
• Heart Attack
• Atherosclerosis
• Coronary Artery Disease
• Peripheral Arterial Disease
• Diabetes

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.