Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESK… (NCT05485961) | Clinical Trial Compass
RecruitingPhase 2/3
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
United States, Argentina, Australia3,110 participantsStarted 2022-10-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is still in a combined Phase 2b and Phase 3 stage, what does that mean for how much is already known about the safety and effectiveness of clazakizumab in people with kidney failure like me?
2The Phase 3 part of this trial is tracking deaths from heart disease and heart attacks — given my current cardiovascular health, does my doctor think my risk level makes this kind of study worth discussing as an option?
3The trial is measuring a protein called hs-CRP as a marker of inflammation — can my doctor tell me what my current hs-CRP level is, and whether lowering inflammation is a realistic treatment goal for my situation?
4Since I'm already on dialysis for end-stage kidney disease, how would participating in this trial fit alongside my existing dialysis schedule, and how frequent would the additional visits or treatments likely be?
5Before considering a trial like this, should I first explore whether there are established heart-protective medications or treatments I haven't tried yet that might address my cardiovascular risk without the uncertainties of an ongoing study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Timeframe: Baseline and up to 12 weeks
2
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)