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 Sex
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
    Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
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

Nephrology of North Alabama
Decatur, Alabama 35601

Nephrology Consultants, LLC
Huntsville, Alabama 35805
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DaVita Clinical Research Montgomery
Montgomery, Alabama 36117
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AKDHC Medical
Glendale, Arizona 85305
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Kidney Disease Medical Group
Glendale, Arizona 91206
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AKDHC Medical
Phoenix, Arizona 85018
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AKDHC Medical
Tucson, Arizona 85705
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Southern Arizona VA Health Care System
Tucson, Arizona 85723
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National Institute of Clinical Research
Bakersfield, California 93309
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Amicis Research Center
Beverly Hills, California 90211
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California Institute of Renal Research
Chula Vista, California 91910
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The Medical Research Group, Inc.
Fresno, California 93720

Davita Fullerton Dialysis Center
Fullerton, California 92832
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National Institute of Clinical Research, Inc.
Fullerton, California 92835
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National Institute of Clinical Research, Inc.
Garden Grove, California 92843
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St. Jude Medical Center
Garden Grove, California 92843
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National Institute of Clinical Research
Garden Grove, California 92844
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Sherman Medical Group, Inc
Glendale, California 91204
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Kidney Disease Medical Group
Glendale, California 91206
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Renal Consultants Medical Group
Granada Hills, California 91344
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Balboa Research
La Jolla, California 92037
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California Institute of Renal Research
La Mesa, California 91942
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Southern California Medical Research Center
La Palma, California 90623
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Academic Medical Research Institute
Los Angeles, California 90022
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National Institute of Clinical Research, Inc.
Los Angeles, California 90027
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Cedars-Sinai Medical Center
Los Angeles, California 90048

Renal Medical Associates/NARI
Lynwood, California 90262
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Amicis Research Center
Northridge, California 91324
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FORMAT Medical Research
Oxnard, California 93036
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Van Buren Dialysis Center
Riverside, California 92504
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National Nephrology Alliance Research - Riverside
Riverside, California 92505
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Central Coast Nephrology Medical Corp
Salinas, California 93901
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California Institute of Renal Research
San Diego, California 92111
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North America Research Institute
San Dimas, California 91773
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Nephrology Educational Services
Tarzana, California 91356
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Valiance Clinical Research
Tarzana, California 91356
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Amicis Research Center
Vacaville, California 95687
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National Institute of Clinical Research, Inc
Victorville, California 92392
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DaVita Vista Del Sol Dialysis
Victorville, California 92394
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Western Nephrology
Arvada, Colorado 80002
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Kidney Associates of Colorado, P.C.
Denver, Colorado 80210
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Colorado Kidney Care
Denver, Colorado 80230
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Greater Hartford Nephrology, LLC
Bloomfield, Connecticut 06002
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Nephrology and Hypertension Associates PC
Middlebury, Connecticut 06762
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Nephrology Associates (Delaware)
Newark, Delaware 19713
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- Boca Raton Regional - Research Physicians Network Alliance
Boca Raton, Florida 33431
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Nova Clinical Research, LLC
Bradenton, Florida 34209
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Access Research Institute
Brooksville, Florida 34613
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Horizon Research Group LLC
Coral Gables, Florida 33134
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South Florida Nephrology Group, PA
Coral Springs, Florida 33071
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Family First Medical Research Center
Hialeah Gardens, Florida 33016
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Advanced Medical Research Group
Hollywood, Florida 33021
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Royal Research, Corp
Hollywood, Florida 33021

Elixia Pines
Hollywood, Florida 33024
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South Florida Research Institute
Lauderdale Lakes, Florida 33313
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South Florida Research Organization LLC
Medley, Florida 33166
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Aviva Health Sciences
Miami, Florida 33125

Iconic Clinical Research Center
Miami, Florida 33126
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Total Research Group, LLC
Miami, Florida 33126
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Kidney and Hypertension Specialists of Miami
Miami, Florida 33150
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Nephrology Associates of South Miami
Miami, Florida 33173
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Floridian Clinical Research
Miami Lakes, Florida 33016
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Elixia Central Florida
Orlando, Florida 32806
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Infigo Clinical Research LLC
Sanford, Florida 32771

Florida Kidney Specialists
Temple Terrace, Florida 33637
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Florida Premier Research Institute
Winter Park, Florida 32789
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Southwest Georgia Nephrology Clinic
Albany, Georgia 31701
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Coastal Medical Research, LLC
Brunswick, Georgia 31520
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Renal Associates LLC
Columbus, Georgia 31904
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National Clinical Trials
Cordele, Georgia 31015

American Clinical Trials
Douglasville, Georgia 30101
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Georgia Nephrology
Lawrenceville, Georgia 30046
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NANI Research
Fort Wayne, Indiana 46804
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Nephrology Physician's LLC
Mishawaka, Indiana 46545
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Dunes Clinical Research LLC
Sioux City, Iowa 57049
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Kansas Nephrology Physicians, PA
Wichita, Kansas 67214
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Nephrology Associates of Kentuckiana, PSC
Louisville, Kentucky 40205
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Renal Associates of Baton Rouge
Baton Rouge, Louisiana 70808
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Tufts Medical Center
Boston, Massachusetts 02111

Massachusetts General Hospital
Boston, Massachusetts 02114
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Paragon Health, Inc
Kalamazoo, Michigan 49007
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Michigan Kidney Consultants, PC
Pontiac, Michigan 48341
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St. Clair Nephrology Research
Roseville, Michigan 48066
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Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan 48081
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DCR Edina
Minneapolis, Minnesota 55404
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Minneapolis VA Health Care System
Minneapolis, Minnesota 55439

Nephrology Associates, PC
Columbus, Mississippi 39705
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- Nephrology and Hypertension Associates Ltd
Tupelo, Mississippi 38801
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Clinical Research Consultants
Kansas City, Missouri 64111
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Clinical Research Consultants
Kansas City, Missouri 64111

Kansas City VA Medical Center
Kansas City, Missouri 64128

DCI-Rockhill
Kansas City, Missouri 64131
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GSR Enterprises, Inc.
Lincoln, Nebraska 68510
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Great Plains Health - Nephrology
North Platte, Nebraska 69101
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DaVita Clinical Research - Henderson
Henderson, Nevada 89074
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Kidney Specialists of Southern Nevada
Las Vegas, Nevada 89106
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Sierra Nevada Specialty Care
Reno, Nevada 89511
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Seacoast Kidney and Hypertension Specialists
Portsmouth, New Hampshire 03801
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Hypertension & Nephrology Association
Eatontown, New Jersey 07724
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New Jersey Kidney Care
Jersey City, New Jersey 07305
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U.S. Renal Care - Gallup
Gallup, New Mexico 87301

SUNY Downstate Medical Center Brooklyn
Brooklyn, New York 11203

Mattoo & Bhat Medical Associates, P.C.
College Point, New York 11356
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NYU Langone Hospital - Long Island
Mineola, New York 11501
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Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York 10467
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James J Peters VA Medical Center
The Bronx, New York 10468

Metrolina Nephrology Associates, PA
Charlotte, North Carolina 28204
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Metrolina Nephrology Associates, PA
Charlotte, North Carolina 28204

Durham Nephrology Associates, PA
Durham, North Carolina 27704
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East Carolina University
Greenville, North Carolina 27858
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North Carolina Nephrology, PA
Raleigh, North Carolina 27610
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Nephrology Associates of the Carolinas
Shelby, North Carolina 28150

HNC Dialysis, Ltd.
Columbus, Ohio 43215
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Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania 18017
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Clinical Renal Associates, LTD
Exton, Pennsylvania 19341

Columbia Nephrology
Columbia, South Carolina 29203
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Dialysis Clinic, Inc.
Spartanburg, South Carolina 29301
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DaVita Clinical Research
Spartanburg, South Carolina 29306
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Southeast Renal Research Institute
Chattanooga, Tennessee 37404
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Dialysis Clinic Inc - University Nephology
Knoxville, Tennessee 37920
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Knoxville Kidney Center PLLC
Knoxville, Tennessee 37923
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Lt. Col. Luke Weathers, Jr. VA Medical Center
Memphis, Tennessee 38105

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Cussimanio Research Group LLC
Austin, Texas 78751
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Research Management, Inc.
Austin, Texas 78758
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Research Management, Inc.
Austin, Texas 78758

MW Clinical Research Center
Beaumont, Texas 77701
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Dallas V.A. Medical Center
Dallas, Texas 75216

Dallas Nephrology Associates
Dallas, Texas 75234

US Renal Care
Dallas, Texas 75237
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Davita Clinical Research
El Paso, Texas 79925
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DaVita Clinical Research - Horizon
El Paso, Texas 79935
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Fort Worth Renal Group
Fort Worth, Texas 76110
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Clinical Research Strategies
Houston, Texas 77030
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DaVita Clinical Research
Houston, Texas 77054
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Aqua Research Institute
Houston, Texas 77058
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Gulf Coast Clinical Research
Houston, Texas 77070

Houston Medical Research Institute, LLC
Houston, Texas 77074
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Clinical Research Strategies, Inc.
Houston, Texas 77090
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Southwest Houston Research
Houston, Texas 77099
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Laguna Clinical Research Associates, LLC
Laredo, Texas 78041
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Prime Clinical Research, Inc.
Mansfield, Texas 76063
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Gamma Medical Research, Inc.
McAllen, Texas 78503
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National Institute of Clinical Research, Inc.
San Antonio, Texas 78204
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DaVita Clinical Research
San Antonio, Texas 78229
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Davita Clinical Research
San Antonio, Texas 78251
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DCR-San Antonio Stone Oak
San Antonio, Texas 78258
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DaVita Clinical Research North Houston
Shenandoah, Texas 77384
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Medrasa Clinical Research
Sherman, Texas 75092
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Renal Research of Montgomery County
The Woodlands, Texas 77384
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DCR-Norfolk Great Bridge
Chesapeake, Virginia 23320
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Nephrology Associates of Northern Virginia Inc
Fairfax, Virginia 22033
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Peninsula Kidney Associates
Hampton, Virginia 23666
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Tidewater Kidney Specialists
Norfolk, Virginia 23502
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Nephrology and Hypertension Associates
Bluefield, West Virginia 24701
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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