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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllCSL Behring
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • CSL300
  • Placebo
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Where

566 sites
Nephrology of North Alabama
Decatur, United States
Nephrology Consultants, LLC
Huntsville, United States
DaVita Clinical Research Montgomery
Montgomery, United States
AKDHC Medical
Glendale, United States
Kidney Disease Medical Group
Glendale, United States
AKDHC Medical
Phoenix, United States
AKDHC Medical
Tucson, United States
Southern Arizona VA Health Care System
Tucson, United States

…and 558 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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