CSL300 for Cardiovascular Health in Dialysis Patients
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Recruiting
Phase 2
Phase 3
Interventional Study
End Stage Kidney Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 3,110 (estimated)
- Sponsor
- CSL Behring · Industry
Who this trial is looking for
This trial is looking for adults with end stage kidney disease who are undergoing dialysis and have systemic inflammation. Participants will receive a study medication or a placebo to see how it affects heart health.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have been diagnosed with end stage kidney disease and am on dialysis for at least 12 weeks.
- My serum hs-CRP level is 2.0 mg/L or higher.
- I have diabetes or atherosclerotic cardiovascular disease.
You may not be able to join if
- I participated in part one of this study.
- I use systemic immunosuppressant drugs.
- I have active tuberculosis.
- I have abnormal liver function tests.
- I have a life-threatening disease that could lead to death within 12 months.
- I have had gastrointestinal perforation, inflammatory bowel disease, or peptic ulcer disease.
- I currently have a significant active infection or a history of certain severe infections.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 di…
Trial Locations
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Eligibility Criteria
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…
Contacts