NCT05485961 · CSL Behring
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
(POSIBIL6ESKD)
What this study is about
This is a 2-part (phase 2b/3) forward-looking, interventional, conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study. Part 1 (phase 2b) is a dose-finding study for CSL300 vs placebo.
View original scientific description
This is a 2-part (phase 2b/3) 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 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.
Interventions
DRUG
CSL300
IV administration
DRUG
Placebo
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
Primary outcome measures
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Time frame: Baseline and up to Week 12
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
Time frame: Approximately 5 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Decatur, Alabama
- Huntsville, Alabama
- Montgomery, Alabama
- Glendale, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Bakersfield, California
- Beverly Hills, California
- Chula Vista, California
- Fresno, California
- Fullerton, California
- Garden Grove, California
And 109 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations