Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
NCT05485961
This study is recruiting at 149 US sites in 32 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- End Stage Kidney Disease
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2/3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- CSL Behring
- Last updated on ClinicalTrials.gov
- September 21, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 3
- Nephrology of North Alabama · Decatur, AL
- Nephrology Consultants, LLC · Huntsville, AL
- DaVita Clinical Research Montgomery · Montgomery, AL
Arizona · 5
- AKDHC Medical · Glendale, AZ
- Kidney Disease Medical Group · Glendale, AZ
- AKDHC Medical · Phoenix, AZ
- AKDHC Medical · Tucson, AZ
- Southern Arizona VA Health Care System · Tucson, AZ
California · 30
- National Institute of Clinical Research · Bakersfield, CA
- California Institute of Renal Research · Chula Vista, CA
- The Medical Research Group, Inc. · Fresno, CA
- Davita Fullerton Dialysis Center · Fullerton, CA
- National Institute of Clinical Research, Inc. · Fullerton, CA
- National Institute of Clinical Research · Garden Grove, CA
- National Institute of Clinical Research, Inc. · Garden Grove, CA
- St. Jude Medical Center · Garden Grove, CA
- Kidney Disease Medical Group · Glendale, CA
- Sherman Medical Group, Inc · Glendale, CA
- Renal Consultants Medical Group · Granada Hills, CA
- Balboa Research · La Jolla, CA
- California Institute of Renal Research · La Mesa, CA
- Southern California Medical Research Center · La Palma, CA
- Academic Medical Research Institute · Los Angeles, CA
- Cedars-Sinai Medical Center · Los Angeles, CA
- National Institute of Clinical Research, Inc. · Los Angeles, CA
- Renal Medical Associates/NARI · Lynwood, CA
- Amicis Research Center · Northridge, CA
- FORMAT Medical Research · Oxnard, CA
- National Institute of Clinical Research, Inc. · Pomona, CA
- National Nephrology Alliance Research - Riverside · Riverside, CA
- Van Buren Dialysis Center · Riverside, CA
- Central Coast Nephrology Medical Corp · Salinas, CA
- California Institute of Renal Research · San Diego, CA
- North America Research Institute · San Dimas, CA
- Nephrology Educational Services · Tarzana, CA
- Valiance Clinical Research · Tarzana, CA
- DaVita Vista Del Sol Dialysis · Victorville, CA
- National Institute of Clinical Research, Inc · Victorville, CA
Colorado · 3
- Western Nephrology · Arvada, CO
- Colorado Kidney Care · Denver, CO
- Kidney Associates of Colorado, P.C. · Denver, CO
Connecticut · 2
- Greater Hartford Nephrology, LLC · Bloomfield, CT
- Nephrology and Hypertension Associates PC · Middlebury, CT
Florida · 17
- - Boca Raton Regional - Research Physicians Network Alliance · Boca Raton, FL
- Nova Clinical Research, LLC · Bradenton, FL
- South Florida Nephrology Group, PA · Coral Springs, FL
- Family First Medical Research Center · Hialeah Gardens, FL
- Advanced Medical Research Group · Hollywood, FL
- Elixia Pines · Hollywood, FL
- Royal Research, Corp · Hollywood, FL
- South Florida Research Institute · Lauderdale Lakes, FL
- South Florida Research Organization LLC · Medley, FL
- Aviva Health Sciences · Miami, FL
- Iconic Clinical Research Center · Miami, FL
- Nephrology Associates of South Miami · Miami, FL
- Total Research Group, LLC · Miami, FL
- Floridian Clinical Research · Miami Lakes, FL
- Infigo Clinical Research LLC · Sanford, FL
- Florida Kidney Specialists · Temple Terrace, FL
- Florida Premier Research Institute · Winter Park, FL
Georgia · 5
- Coastal Medical Research, LLC · Brunswick, GA
- Renal Associates LLC · Columbus, GA
- National Clinical Trials · Cordele, GA
- American Clinical Trials · Douglasville, GA
- Georgia Nephrology · Lawrenceville, GA
Indiana · 2
- NANI Research · Fort Wayne, IN
- Nephrology Physician's LLC · Mishawaka, IN
Iowa · 1
- Dunes Clinical Research LLC · Sioux City, IA
Kansas · 1
- Kansas Nephrology Physicians, PA · Wichita, KS
Kentucky · 1
- Nephrology Associates of Kentuckiana, PSC · Louisville, KY
Louisiana · 1
- Renal Associates of Baton Rouge · Baton Rouge, LA
Massachusetts · 2
- Massachusetts General Hospital · Boston, MA
- Tufts Medical Center · Boston, MA
Michigan · 4
- Paragon Health, Inc · Kalamazoo, MI
- Michigan Kidney Consultants, PC · Pontiac, MI
- St. Clair Nephrology Research · Roseville, MI
- Center for Advanced Kidney Research, PLC · Saint Clair Shores, MI
Minnesota · 2
- DCR Edina · Minneapolis, MN
- Minneapolis VA Health Care System · Minneapolis, MN
Mississippi · 2
- Nephrology Associates, PC · Columbus, MS
- - Nephrology and Hypertension Associates Ltd · Tupelo, MS
Missouri · 3
- Clinical Research Consultants · Kansas City, MO
- DCI-Rockhill · Kansas City, MO
- Kansas City VA Medical Center · Kansas City, MO
Nebraska · 2
- GSR Enterprises, Inc. · Lincoln, NE
- Great Plains Health - Nephrology · North Platte, NE
Nevada · 3
- DaVita Clinical Research - Henderson · Henderson, NV
- Kidney Specialists of Southern Nevada · Las Vegas, NV
- Sierra Nevada Specialty Care · Reno, NV
New Hampshire · 1
- Seacoast Kidney and Hypertension Specialists · Portsmouth, NH
New Jersey · 2
- Hypertension & Nephrology Association · Eatontown, NJ
- New Jersey Kidney Care · Jersey City, NJ
New Mexico · 1
- U.S. Renal Care - Gallup · Gallup, NM
New York · 6
- Albany Medical College Committee of Research Involving Human Subjects · Albany, NY
- SUNY Downstate Medical Center Brooklyn · Brooklyn, NY
- Mattoo & Bhat Medical Associates, P.C. · College Point, NY
- NYU Langone Hospital - Long Island · Mineola, NY
- Albert Einstein College of Medicine - Montefiore Medical Center · The Bronx, NY
- James J Peters VA Medical Center · The Bronx, NY
North Carolina · 6
- Metrolina Nephrology Associates, PA · Charlotte, NC
- Duke Translational Medicine Institute · Durham, NC
- Durham Nephrology Associates, PA · Durham, NC
- East Carolina University · Greenville, NC
- North Carolina Nephrology, PA · Raleigh, NC
- Nephrology Associates of the Carolinas · Shelby, NC
Ohio · 1
- HNC Dialysis, Ltd. · Columbus, OH
Pennsylvania · 2
- Northeast Clinical Research Center, LLC · Bethlehem, PA
- Clinical Renal Associates, LTD · Exton, PA
Rhode Island · 1
- Lifespan Clinical Research · East Providence, RI
South Carolina · 4
- Columbia Nephrology · Columbia, SC
- CN Clinical Research LLC · Greenville, SC
- DaVita Clinical Research · Spartanburg, SC
- Dialysis Clinic, Inc. · Spartanburg, SC
Tennessee · 5
- Southeast Renal Research Institute · Chattanooga, TN
- Dialysis Clinic Inc - University Nephology · Knoxville, TN
- Knoxville Kidney Center PLLC · Knoxville, TN
- Lt. Col. Luke Weathers, Jr. VA Medical Center · Memphis, TN
- Vanderbilt University Medical Center · Nashville, TN
Texas · 25
- Cussimanio Research Group LLC · Austin, TX
- Research Management, Inc. · Austin, TX
- MW Clinical Research Center · Beaumont, TX
- Dallas Nephrology Associates · Dallas, TX
- Dallas V.A. Medical Center · Dallas, TX
- US Renal Care · Dallas, TX
- Davita Clinical Research · El Paso, TX
- DaVita Clinical Research - Horizon · El Paso, TX
- Fort Worth Renal Group · Fort Worth, TX
- Aqua Research Institute · Houston, TX
- Clinical Research Strategies · Houston, TX
- Clinical Research Strategies, Inc. · Houston, TX
- DaVita Clinical Research · Houston, TX
- Gulf Coast Clinical Research · Houston, TX
- Houston Medical Research Institute, LLC · Houston, TX
- Southwest Houston Research · Houston, TX
- Prime Clinical Research, Inc. · Mansfield, TX
- Gamma Medical Research, Inc. · McAllen, TX
- Davita Clinical Research · San Antonio, TX
- DaVita Clinical Research · San Antonio, TX
- DCR-San Antonio Stone Oak · San Antonio, TX
- National Institute of Clinical Research, Inc. · San Antonio, TX
- DaVita Clinical Research North Houston · Shenandoah, TX
- Medrasa Clinical Research · Sherman, TX
- Renal Research of Montgomery County · The Woodlands, TX
Virginia · 5
- DCR-Norfolk Great Bridge · Chesapeake, VA
- Nephrology Associates of Northern Virginia Inc · Fairfax, VA
- Peninsula Kidney Associates · Hampton, VA
- Tidewater Kidney Specialists · Norfolk, VA
- Richmond V.A. Medical Center · Richmond, VA
West Virginia · 1
- Nephrology and Hypertension Associates · Bluefield, WV
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.