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Bored Studies
RecruitingPhase 2/Phase 3

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

CSL Behring · NCT05485961

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2, Phase 3
Target enrollment
3110
US sites recruiting
149
Study start
April 27, 2024
Record last updated
September 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: CSL300; Placebo

Conditions: End Stage Kidney Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 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.

Recruiting US locations

  • Nephrology of North Alabama

    Decatur, AL 35601

  • Nephrology Consultants, LLC

    Huntsville, AL 35805

    Site contact: Use Central Contact

  • DaVita Clinical Research Montgomery

    Montgomery, AL 36117

    Site contact: Use Central Contact

  • AKDHC Medical

    Glendale, AZ 85305

    Site contact: Use Central Contact

  • Kidney Disease Medical Group

    Glendale, AZ 91206

    Site contact: Use Central Contact

  • AKDHC Medical

    Phoenix, AZ 85018

    Site contact: Use Central Contact

  • AKDHC Medical

    Tucson, AZ 85705

    Site contact: Use Central Contact

  • Southern Arizona VA Health Care System

    Tucson, AZ 85723

    Site contact: Trial Information Contact

  • National Institute of Clinical Research

    Bakersfield, CA 93309

    Site contact: Use Central Contact

  • California Institute of Renal Research

    Chula Vista, CA 91910

    Site contact: Use Central Contact

  • The Medical Research Group, Inc.

    Fresno, CA 93720

  • Davita Fullerton Dialysis Center

    Fullerton, CA 92832

    Site contact: Use Central Contact

  • National Institute of Clinical Research, Inc.

    Fullerton, CA 92835

    Site contact: Use Central Contact

  • National Institute of Clinical Research, Inc.

    Garden Grove, CA 92843

    Site contact: Use Central Contact

  • St. Jude Medical Center

    Garden Grove, CA 92843

    Site contact: Use Central Contact

  • National Institute of Clinical Research

    Garden Grove, CA 92844

    Site contact: Use Central Contact

  • Sherman Medical Group, Inc

    Glendale, CA 91204

    Site contact: Use Central Contact

  • Kidney Disease Medical Group

    Glendale, CA 91206

    Site contact: Use Central Contact

  • Renal Consultants Medical Group

    Granada Hills, CA 91344

    Site contact: Use Central Contact

  • Balboa Research

    La Jolla, CA 92037

    Site contact: Trial Information Contact

  • California Institute of Renal Research

    La Mesa, CA 91942

    Site contact: Use Central Contact

  • Southern California Medical Research Center

    La Palma, CA 90623

    Site contact: Use Central Contact

  • Academic Medical Research Institute

    Los Angeles, CA 90022

    Site contact: Use Central Contact

  • National Institute of Clinical Research, Inc.

    Los Angeles, CA 90027

    Site contact: Use Central Contact

  • Cedars-Sinai Medical Center

    Los Angeles, CA 90048

  • Renal Medical Associates/NARI

    Lynwood, CA 90262

    Site contact: Use Central Contact

  • Amicis Research Center

    Northridge, CA 91324

    Site contact: Use Central Contact

  • FORMAT Medical Research

    Oxnard, CA 93036

    Site contact: Use Central Contact

  • National Institute of Clinical Research, Inc.

    Pomona, CA 91768

  • Van Buren Dialysis Center

    Riverside, CA 92504

    Site contact: Use Central Contact

  • National Nephrology Alliance Research - Riverside

    Riverside, CA 92505

    Site contact: Use Central Contact

  • Central Coast Nephrology Medical Corp

    Salinas, CA 93901

    Site contact: Use Central Contact

  • California Institute of Renal Research

    San Diego, CA 92111

    Site contact: Use Central Contact

  • North America Research Institute

    San Dimas, CA 91773

    Site contact: Use Central Contact

  • Nephrology Educational Services

    Tarzana, CA 91356

    Site contact: Use Central Contact

  • Valiance Clinical Research

    Tarzana, CA 91356

    Site contact: Use Central Contact

  • National Institute of Clinical Research, Inc

    Victorville, CA 92392

    Site contact: Use Central Contact

  • DaVita Vista Del Sol Dialysis

    Victorville, CA 92394

    Site contact: Use Central Contact

  • Western Nephrology

    Arvada, CO 80002

    Site contact: Trial Information Contact · 303-232-3366 · kmydosh@westneph.com

  • Kidney Associates of Colorado, P.C.

    Denver, CO 80210

    Site contact: Use Central Contact

  • Colorado Kidney Care

    Denver, CO 80230

    Site contact: Use Central Contact

  • Greater Hartford Nephrology, LLC

    Bloomfield, CT 06002

    Site contact: Use Central Contact

  • Nephrology and Hypertension Associates PC

    Middlebury, CT 06762

    Site contact: Use Central Contact

  • - Boca Raton Regional - Research Physicians Network Alliance

    Boca Raton, FL 33431

    Site contact: Use Central Contact

  • Nova Clinical Research, LLC

    Bradenton, FL 34209

    Site contact: Trial Information Contact · 941-792-6564 · sade.andrews@novaclinicalresearch.com

  • South Florida Nephrology Group, PA

    Coral Springs, FL 33071

    Site contact: Use Central Contact

  • Family First Medical Research Center

    Hialeah Gardens, FL 33016

    Site contact: Use Central Contact

  • Advanced Medical Research Group

    Hollywood, FL 33021

    Site contact: Use Central Contact

  • Royal Research, Corp

    Hollywood, FL 33021

  • Elixia Pines

    Hollywood, FL 33024

    Site contact: Use Central Contact

  • South Florida Research Institute

    Lauderdale Lakes, FL 33313

    Site contact: Use Central Contact

  • South Florida Research Organization LLC

    Medley, FL 33166

    Site contact: Use Central Contact

  • Aviva Health Sciences

    Miami, FL 33125

  • Iconic Clinical Research Center

    Miami, FL 33126

    Site contact: Use Central Contact

  • Total Research Group, LLC

    Miami, FL 33126

    Site contact: Use Central Contact

  • Nephrology Associates of South Miami

    Miami, FL 33173

    Site contact: Use Central Contact

  • Floridian Clinical Research

    Miami Lakes, FL 33016

    Site contact: Use Central Contact

  • Infigo Clinical Research LLC

    Sanford, FL 32771

  • Florida Kidney Specialists

    Temple Terrace, FL 33637

    Site contact: Use Central Contact

  • Florida Premier Research Institute

    Winter Park, FL 32789

    Site contact: Use Central Contact

+ 89 more on the official record.

Study contacts (from the official record)

  • Trial Registration Coordinator · +1 610-878-4697 · clinicaltrials@cslbehring.com
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Combined Dose-Finding and CV Outcomes Study With CSL300… (NCT05485961) | Bored Studies