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Phase 2Recruiting

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

Sponsored by CSL Behring

About this study

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.

Where this study is enrolling (20)

  • Southern Arizona VA Health Care System

    Tucson, Arizona

    Call 520-792-1450

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  • AKDHC Medical

    Glendale, Arizona

    Call 602-997-0484

    This research site can be reached directly by phone. Call to ask about this study.

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  • Kidney Disease Medical Group

    Glendale, Arizona

    Call 602-997-0484

    This research site can be reached directly by phone. Call to ask about this study.

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  • AKDHC Medical

    Tucson, Arizona

    Call 602-997-0484

    This research site can be reached directly by phone. Call to ask about this study.

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  • Western Nephrology

    Arvada, Colorado

    I'm interested
Show all 20 locations

  • Nova Clinical Research, LLC

    Bradenton, Florida

    I'm interested

  • Georgia Nephrology

    Lawrenceville, Georgia

    I'm interested

  • Massachusetts General Hospital

    Boston, Massachusetts

    I'm interested

  • Southeast Renal Research Institute

    Chattanooga, Tennessee

    I'm interested

  • DaVita Clinical Research

    Houston, Texas

    Call 888-345-2567

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  • Aqua Research Institute

    Houston, Texas

    I'm interested

  • Clinical Research Strategies

    Houston, Texas

    I'm interested

  • Clinical Research Strategies, Inc.

    Houston, Texas

    I'm interested

  • Renal Research of Montgomery County

    The Woodlands, Texas

    Call 936-756-2555

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  • Gulf Coast Clinical Research

    Houston, Texas

    I'm interested

  • Houston Medical Research Institute, LLC

    Houston, Texas

    Call 713.790.3333

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  • Peninsula Kidney Associates

    Hampton, Virginia

    I'm interested

  • DCR-Norfolk Great Bridge

    Chesapeake, Virginia

    I'm interested

  • Tidewater Kidney Specialists

    Norfolk, Virginia

    I'm interested

  • Nephrology Associates of Northern Virginia Inc

    Fairfax, Virginia

    I'm interested
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.