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

Purpose

This is a 2-part (phase 2b/3) 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 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.

Conditions

  • Atherosclerotic Cardiovascular Disease
  • End Stage Kidney Disease
  • Atherosclerotic Cardiovascular Disease in Patients With ESKD

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CSL300 (low dose)(Phase 2b) 		Intravenous (IV) administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Experimental
CSL300 (medium dose)(Phase 2b) 		IV administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Experimental
CSL300 (high dose)(Phase 2b) 		IV administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Placebo Comparator
Placebo (Phase 2b) 		IV administration
  • Drug: Placebo
    0.9% w/v NaCl
Experimental
CSL300 (Phase 3) 		IV administration
  • Drug: CSL300
    IV administration
    Other names:
    • Clazakizumab
Placebo Comparator
Placebo (Phase 3) 		IV administration
  • Drug: Placebo
    Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Recruiting Locations

84000149 - Nephrology Consultants, LLC
Huntsville, Alabama 35805
Contact:
Use Central Contact

84000340 - DaVita Clinical Research Montgomery
Montgomery, Alabama 36117
Contact:
Use Central Contact

84000552 - AKDHC Medical
Glendale, Arizona 85305
Contact:
Use Central Contact

84000178 - Kidney Disease Medical Group
Glendale, Arizona 91206
Contact:
Use Central Contact

84000231 - AKDHC Medical
Phoenix, Arizona 85018
Contact:
Use Central Contact

84000286 - AKDHC Medical
Tucson, Arizona 85705
Contact:
Use Central Contact

84000145 - National Institute of Clinical Research
Bakersfield, California 93309
Contact:
Use Central Contact

84000151 - National Institute of Clinical Research
Bakersfield, California 93309
Contact:
Use Central Contact

84000277 - Amicis Research Center
Beverly Hills, California 90211
Contact:
Use Central Contact

84000241 - California Institute of Renal Research
Chula Vista, California 91910
Contact:
Use Central Contact

84000462 - Davita Fullerton Dialysis Center
Fullerton, California 92832
Contact:
Use Central Contact

84000574 - National Institute of Clinical Research, Inc.
Fullerton, California 92835
Contact:
Use Central Contact

84000464 - St. Jude Medical Center
Garden Grove, California 92843
Contact:
Use Central Contact

84000573 - National Institute of Clinical Research, Inc.
Garden Grove, California 92843
Contact:
Use Central Contact

84000152 - National Institute of Clinical Research
Garden Grove, California 92844
Contact:
Use Central Contact

84000531 - Sherman Medical Group, Inc
Glendale, California 91204
Contact:
Use Central Contact

84000230 - Kidney Disease Medical Group
Glendale, California 91206
Contact:
Use Central Contact

84000379 - Renal Consultants Medical Group
Granada Hills, California 91344
Contact:
Use Central Contact

84000221 - California Institute of Renal Research
La Mesa, California 91942
Contact:
Use Central Contact

84000235 - California Institute of Renal Research
La Mesa, California 91942
Contact:
Use Central Contact

84000198 - Southern California Medical Research Center
La Palma, California 90623
Contact:
Use Central Contact

84000467 - Southern California Medical Research Center
La Palma, California 90623
Contact:
Use Central Contact

84000329 - Academic Medical Research Institute
Los Angeles, California 90022
Contact:
Use Central Contact

84000439 - National Institute of Clinical Research, Inc.
Los Angeles, California 90027
Contact:
Use Central Contact

84000175 - Renal Medical Associates/NARI
Lynwood, California 90262
Contact:
Use Central Contact

84000279 - Amicis Research Center
Northridge, California 91324
Contact:
Use Central Contact

84000533 - FORMAT Medical Research
Oxnard, California 93036
Contact:
Use Central Contact

84000331 - Van Buren Dialysis Center
Riverside, California 92504
Contact:
Use Central Contact

84000228 - National Nephrology Alliance Research - Riverside
Riverside, California 92505
Contact:
Use Central Contact

84000492 - Central Coast Nephrology Medical Corp
Salinas, California 93901
Contact:
Use Central Contact

84000238 - California Institute of Renal Research
San Diego, California 92111
Contact:
Use Central Contact

84000330 - North America Research Institute
San Dimas, California 91773
Contact:
Use Central Contact

84000341 - North America Research Institute
San Dimas, California 91773
Contact:
Use Central Contact

84000440 - Nephrology Educational Services
Tarzana, California 91356
Contact:
Use Central Contact

84000278 - Amicis Research Center
Vacaville, California 95687
Contact:
Use Central Contact

84000323 - National Institute of Clinical Research, Inc
Victorville, California 92392
Contact:
Use Central Contact

84000174 - DaVita Vista Del Sol Dialysis
Victorville, California 92394
Contact:
Use Central Contact

84000454 - Kidney Associates of Colorado, P.C.
Denver, Colorado 80210
Contact:
Use Central Contact

84000223 - Colorado Kidney Care
Denver, Colorado 80230
Contact:
Use Central Contact

84000176 - Greater Hartford Nephrology, LLC
Bloomfield, Connecticut 06002
Contact:
Use Central Contact

84000173 - Nephrology and Hypertension Associates PC
Middlebury, Connecticut 06762
Contact:
Use Central Contact

84000494 - Nephrology Associates (Delaware)
Newark, Delaware 19713
Contact:
Use Central Contact

84000441 - Boca Raton Regional - Research Physicians Network Alliance
Boca Raton, Florida 33431
Contact:
Use Central Contact

84000193 - Horizon Research Group LLC
Coral Gables, Florida 33134
Contact:
Use Central Contact

84000443 - South Florida Nephrology Group, PA
Coral Springs, Florida 33071
Contact:
Use Central Contact

84000597 - Family First Medical Research Center
Hialeah Gardens, Florida 33016
Contact:
Use Central Contact

84000406 - Elixia Pines
Hollywood, Florida 33024
Contact:
Use Central Contact

84000140 -South Florida Research Institute
Lauderdale Lakes, Florida 33313
Contact:
Use Central Contact

84000599 - South Florida Research Organization LLC
Medley, Florida 33166
Contact:
Use Central Contact

84000527 - Floridian Clinical Research
Miami Lakes, Florida 33016
Contact:
Use Central Contact

84000495 - Total Research Group, LLC
Miami, Florida 33126
Contact:
Use Central Contact

84000362 - Kidney and Hypertension Specialists of Miami
Miami, Florida 33150
Contact:
Use Central Contact

84000182 - Nephrology Associates of South Miami
Miami, Florida 33173
Contact:
Use Central Contact

84000400 - Elixia Central Florida
Orlando, Florida 32806
Contact:
Use Central Contact

84000532 - Florida Kidney Specialists
Temple Terrace, Florida 33637
Contact:
Use Central Contact

84000426 - Florida Premier Research Institute
Winter Park, Florida 32789
Contact:
Use Central Contact

84000326 - Coastal Medical Research, LLC
Brunswick, Georgia 31520
Contact:
Use Central Contact

84000157 - Renal Associates LLC
Columbus, Georgia 31904
Contact:
Use Central Contact

84000327 - American Clinical Trials
Douglasville, Georgia 30101
Contact:
Use Central Location

84000453 - Nephrology Physician's LLC
Mishawaka, Indiana 46545
Contact:
Use Central Contact

84000534 - Dunes Clinical Research LLC
Sioux City, Iowa 57049
Contact:
Use Central Contact

84000374 - Kansas Nephrology Physicians, PA
Wichita, Kansas 67214
Contact:
Use Central Contact

84000554 - Nephrology Associates of Kentuckiana, PSC
Louisville, Kentucky 40205
Contact:
Use Central Contact

84000550 - Renal Associates of Baton Rouge
Baton Rouge, Louisiana 70808
Contact:
Use Central Contact

84000465 - Paragon Health, Inc
Kalamazoo, Michigan 49007
Contact:
Use Central Contact

84000408 - Michigan Kidney Consultants, PC
Pontiac, Michigan 48341
Contact:
Use Central Contact

84000171 - St. Clair Nephrology Research
Roseville, Michigan 48066
Contact:
Use Central Contact

84000237 - Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan 48081
Contact:
Use Central Contact

84000338 - DCR Edina
Minneapolis, Minnesota 55404
Contact:
Use Central Contact

84000153 - Nephrology Associates, PC
Columbus, Mississippi 39705
Contact:
Use Central Contact

84000144 - Nephrology and Hypertension Associates Ltd
Tupelo, Mississippi 38801
Contact:
Use Central Contact

84000147 - Clinical Research Consultants
Kansas City, Missouri 64111
Contact:
Use Central Contact

84000328 - GSR Enterprises, Inc.
Lincoln, Nebraska 68510
Contact:
Use Central Contact

84000222 - Great Plains Health - Nephrology
North Platte, Nebraska 69101
Contact:
Use Central Contact

84000420 - DaVita Clinical Research - Henderson
Henderson, Nevada 89074
Contact:
Use Central Contact

84000337 - Kidney Specialists of Southern Nevada
Las Vegas, Nevada 89106
Contact:
Use Central Contact

84000148 - Sierra Nevada Specialty Care
Reno, Nevada 89511
Contact:
Use Central Contact

84000141 - Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire 03801
Contact:
Use Central Contact

84000436 - Hypertension & Nephrology Association
Eatontown, New Jersey 07724
Contact:
Use Central Contact

84000452 - New Jersey Kidney Care
Jersey City, New Jersey 07305
Contact:
Use Central Contact

84000276 - Albert Einstein College of Medicine - Montefiore Medical Center
Bronx, New York 10467
Contact:
Use Central Contact

84000184 - Mattoo & Bhat Medical Associates, P.C.
College Point, New York 11356
Contact:
Use Central Contact

84000191 - Metrolina Nephrology Associates, PA
Charlotte, North Carolina 28204
Contact:
Use Central Contact

84000150 - Durham Nephrology Associates, PA
Durham, North Carolina 27704
Contact:
Use Central Contact

84000232 - East Carolina University
Greenville, North Carolina 27858
Contact:
Use Central Contact

84000410 - North Carolina Nephrology, PA
Raleigh, North Carolina 27610
Contact:
Use Central Location

84000548 - HNC Dialysis, Ltd.
Columbus, Ohio 43215
Contact:
Use Central Contact

84000234 - Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania 18017
Contact:
Use Central Contact

84000192 - Columbia Nephrology
Columbia, South Carolina 29203
Contact:
Use Central Contact

84000229 - DaVita Clinical Research
Spartanburg, South Carolina 29306
Contact:
Use Central Contact

84000180 - Knoxville Kidney Center PLLC
Knoxville, Tennessee 37923
Contact:
Use Central Contact

84000451 - Cussimanio Research Group LLC
Austin, Texas 78751
Contact:
Use Central Contact

84000438 - Research Management, Inc.
Austin, Texas 78758
Contact:
Use Central Contact

84000549 - MW Clinical Research Center
Beaumont, Texas 77701
Contact:
Use Central Contact

84000457 - US Renal Care
Dallas, Texas 75237
Contact:
Use Central Contact

84000354 - Davita Clinical Research
El Paso, Texas 79925
Contact:
Use Central Contact

84000421 - DaVita Clinical Research - Horizon
El Paso, Texas 79935
Contact:
Use Central Contact

84000458 - Fort Worth Renal Group
Fort Worth, Texas 76110
Contact:
Use Central Contact

84000350 - DaVita Clinical Research
Houston, Texas 77054
Contact:
Use Central Contact

84000498 - DaVita Clinical Research
Houston, Texas 77054
Contact:
Use Central Contact

84000598 - Aqua Research Institute
Houston, Texas 77058
Contact:
Use Central Contact

84000450 - Houston Medical Research Institute, LLC
Houston, Texas 77074
Contact:
Use Central Contact

84000360 - Clinical Research Strategies, Inc.
Houston, Texas 77090
Contact:
Use Central Contact

84000196 - Southwest Houston Research
Houston, Texas 77099
Contact:
Use Central Contact

84000373 - Gamma Medical Research, Inc.
McAllen, Texas 78503
Contact:
Use Central Location

84000324 - National Institute of Clinical Research, Inc.
San Antonio, Texas 78204
Contact:
Use Central Contact

84000351 - DaVita Clinical Research
San Antonio, Texas 78229
Contact:
Use Central Contact

84000419 - Davita Clinical Research
San Antonio, Texas 78251
Contact:
Use Central Contact

84000553 - DCR-San Antonio Stone Oak
San Antonio, Texas 78258
Contact:
Use Central Contact

84000339 - DaVita Clinical Research North Houston
Shenandoah, Texas 77384
Contact:
Use Central Contact

84000535 - DCR-Norfolk Great Bridge
Chesapeake, Virginia 23320
Contact:
Use Central Contact

84000424 - Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia 22033
Contact:
Use Central Contact

84000138 - Peninsula Kidney Associates
Hampton, Virginia 23666
Contact:
Use Central Contact

84000156 - Tidewater Kidney Specialists
Norfolk, Virginia 23502
Contact:
Use Central Contact

84000336 - Nephrology and Hypertension Associates
Bluefield, West Virginia 24701
Contact:
Use Central Contact

More Details

NCT ID
NCT05485961
Status
Recruiting
Sponsor
CSL Behring

Study Contact

Trial Registration Coordinator
+1 610-878-4697
clinicaltrials@cslbehring.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center