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CSL300 for End Stage Kidney Disease and Inflammation

This study is testing CSL300 (Clazakizumab) for adults with End Stage Kidney Disease (ESKD), also known as kidney failure, who are on dialysis and have inflammation. The study has two parts: the first part (Phase 2b) will help determine the best dose of CSL300, and the second part (Phase 3) will compare CSL300 to a placebo (an inactive substance) to see if it can reduce serious heart-related problems like heart attack or cardiovascular death over about 5 years. You may be able to join if you are at least 18, have ESKD and are on dialysis, have a certain level of inflammation (hs-CRP ≥ 2.0 mg/L), and also have diabetes or a history of heart disease (ASCVD). The study is currently unclear about its recruitment status and plans to enroll 3110 participants.

Study design
This is a two-part study (Phase 2b and Phase 3) that is randomized, double-blind (meaning neither you nor your doctor will know if you're receiving CSL300 or placebo), and placebo-controlled, involving 3110 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track participants for about 5 years to see the first occurrence of cardiovascular death or myocardial infarction (heart attack).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05485961

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
CSL Behring
~3,110 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:CSL300Placebo

At a glance

Recruiting sites
507 of 557 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Measured over Baseline and up to Week 12
+1 more outcome measured

Conditions

End Stage Kidney Disease

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Where it's being run

557 sites across 82 states
China40
California35
Italy29
Japan28
Texas26
Florida22
Brazil22
Spain21

Study leadership

  • Study Director · STUDY_DIRECTOR · CSL Behring LLC

Who to contact

Trial Registration Coordinator
[email protected]
+1 610-878-4697
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)Baseline and up to Week 12
  • Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)Approximately 5 years