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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

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
    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 4068590, Alabama 4829764 35805
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84000340 - DaVita Clinical Research Montgomery
Montgomery 4076784, Alabama 4829764 36117
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84000552 - AKDHC Medical
Glendale 5295985, Arizona 5551752 85305
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84000178 - Kidney Disease Medical Group
Glendale 5295985, Arizona 5551752 91206
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84000231 - AKDHC Medical
Phoenix 5308655, Arizona 5551752 85018
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84000286 - AKDHC Medical
Tucson 5318313, Arizona 5551752 85705
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84000145 - National Institute of Clinical Research
Bakersfield 5325738, California 5332921 93309
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84000151 - National Institute of Clinical Research
Bakersfield 5325738, California 5332921 93309
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84000277 - Amicis Research Center
Beverly Hills 5328041, California 5332921 90211
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84000241 - California Institute of Renal Research
Chula Vista 5336899, California 5332921 91910
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84000462 - Davita Fullerton Dialysis Center
Fullerton 5351247, California 5332921 92832
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84000574 - National Institute of Clinical Research, Inc.
Fullerton 5351247, California 5332921 92835
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84000464 - St. Jude Medical Center
Garden Grove 5351515, California 5332921 92843
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84000573 - National Institute of Clinical Research, Inc.
Garden Grove 5351515, California 5332921 92843
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84000152 - National Institute of Clinical Research
Garden Grove 5351515, California 5332921 92844
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84000531 - Sherman Medical Group, Inc
Glendale 5352423, California 5332921 91204
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84000230 - Kidney Disease Medical Group
Glendale 5352423, California 5332921 91206
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84000379 - Renal Consultants Medical Group
Granada Hills 5353433, California 5332921 91344
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84000631 - Balboa Research
La Jolla 5363943, California 5332921 92037
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84000221 - California Institute of Renal Research
La Mesa 5363990, California 5332921 91942
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84000235 - California Institute of Renal Research
La Mesa 5363990, California 5332921 91942
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84000198 - Southern California Medical Research Center
La Palma 5364022, California 5332921 90623
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84000467 - Southern California Medical Research Center
La Palma 5364022, California 5332921 90623
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84000329 - Academic Medical Research Institute
Los Angeles 5368361, California 5332921 90022
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84000439 - National Institute of Clinical Research, Inc.
Los Angeles 5368361, California 5332921 90027
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84000175 - Renal Medical Associates/NARI
Lynwood 5369367, California 5332921 90262
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84000279 - Amicis Research Center
Northridge 5377985, California 5332921 91324
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84000533 - FORMAT Medical Research
Oxnard 5380184, California 5332921 93036
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84000331 - Van Buren Dialysis Center
Riverside 5387877, California 5332921 92504
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84000228 - National Nephrology Alliance Research - Riverside
Riverside 5387877, California 5332921 92505
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84000492 - Central Coast Nephrology Medical Corp
Salinas 5391295, California 5332921 93901
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84000238 - California Institute of Renal Research
San Diego 5391811, California 5332921 92111
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84000330 - North America Research Institute
San Dimas 5391891, California 5332921 91773
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84000341 - North America Research Institute
San Dimas 5391891, California 5332921 91773
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84000440 - Nephrology Educational Services
Tarzana 5401143, California 5332921 91356
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84000536 - Valiance Clinical Research
Tarzana 5401143, California 5332921 91356
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84000278 - Amicis Research Center
Vacaville 5405228, California 5332921 95687
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84000323 - National Institute of Clinical Research, Inc
Victorville 5406222, California 5332921 92392
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84000174 - DaVita Vista Del Sol Dialysis
Victorville 5406222, California 5332921 92394
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84000589 - Western Nephrology
Arvada 5412199, Colorado 5417618 80002
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303-232-3366
kmydosh@westneph.com

84000454 - Kidney Associates of Colorado, P.C.
Denver 5419384, Colorado 5417618 80210
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84000223 - Colorado Kidney Care
Denver 5419384, Colorado 5417618 80230
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84000176 - Greater Hartford Nephrology, LLC
Bloomfield 5282526, Connecticut 4831725 06002
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84000173 - Nephrology and Hypertension Associates PC
Middlebury 4838611, Connecticut 4831725 06762
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84000494 - Nephrology Associates (Delaware)
Newark 4143861, Delaware 4142224 19713
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84000441 - Boca Raton Regional - Research Physicians Network Alliance
Boca Raton 4148411, Florida 4155751 33431
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84000779 - Nova Clinical Research, LLC
Bradenton 4148708, Florida 4155751 34209
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941-792-6564
sade.andrews@novaclinicalresearch.com

84000661 - Access Research Institute
Brooksville 4148986, Florida 4155751 34613
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84000193 - Horizon Research Group LLC
Coral Gables 4151871, Florida 4155751 33134
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84000443 - South Florida Nephrology Group, PA
Coral Springs 4151909, Florida 4155751 33071
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84000597 - Family First Medical Research Center
Hialeah Gardens 4158482, Florida 4155751 33016
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84000650 - Advanced Medical Research Group
Hollywood 4158928, Florida 4155751 33021
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84000406 - Elixia Pines
Hollywood 4158928, Florida 4155751 33024
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84000140 -South Florida Research Institute
Lauderdale Lakes 4161616, Florida 4155751 33313
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84000599 - South Florida Research Organization LLC
Medley 4163952, Florida 4155751 33166
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84000495 - Total Research Group, LLC
Miami 4164138, Florida 4155751 33126
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84000663 - Iconic Clinical Research Center
Miami 4164138, Florida 4155751 33126
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84000362 - Kidney and Hypertension Specialists of Miami
Miami 4164138, Florida 4155751 33150
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84000182 - Nephrology Associates of South Miami
Miami 4164138, Florida 4155751 33173
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84000527 - Floridian Clinical Research
Miami Lakes 4164186, Florida 4155751 33016
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84000400 - Elixia Central Florida
Orlando 4167147, Florida 4155751 32806
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84000532 - Florida Kidney Specialists
Temple Terrace 4174969, Florida 4155751 33637
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84000426 - Florida Premier Research Institute
Winter Park 4178560, Florida 4155751 32789
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84000366 - Southwest Georgia Nephrology Clinic
Albany 4179320, Georgia 4197000 31701
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84000326 - Coastal Medical Research, LLC
Brunswick 4184845, Georgia 4197000 31520
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84000157 - Renal Associates LLC
Columbus 4188985, Georgia 4197000 31904
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84000327 - American Clinical Trials
Douglasville 4191955, Georgia 4197000 30101
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84000582 - Georgia Nephrology
Lawrenceville 4205196, Georgia 4197000 30046
Contact:
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404-664-7631
afelder@nephronet.com

84000528 - NANI Research
Fort Wayne 4920423, Indiana 4921868 46804
Contact:
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84000453 - Nephrology Physician's LLC
Mishawaka 4923670, Indiana 4921868 46545
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84000534 - Dunes Clinical Research LLC
Sioux City 4876523, Iowa 4862182 57049
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84000374 - Kansas Nephrology Physicians, PA
Wichita 4281730, Kansas 4273857 67214
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84000554 - Nephrology Associates of Kentuckiana, PSC
Louisville 4299276, Kentucky 6254925 40205
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84000550 - Renal Associates of Baton Rouge
Baton Rouge 4315588, Louisiana 4331987 70808
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84000220 - Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
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617-724-8839
hbouchouari@mgh.harvard.edu

84000465 - Paragon Health, Inc
Kalamazoo 4997787, Michigan 5001836 49007
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84000408 - Michigan Kidney Consultants, PC
Pontiac 5006166, Michigan 5001836 48341
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84000171 - St. Clair Nephrology Research
Roseville 5007655, Michigan 5001836 48066
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84000237 - Center for Advanced Kidney Research, PLC
Saint Clair Shores 5010978, Michigan 5001836 48081
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84000338 - DCR Edina
Minneapolis 5037649, Minnesota 5037779 55404
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84000153 - Nephrology Associates, PC
Columbus 4422442, Mississippi 4436296 39705
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84000144 - Nephrology and Hypertension Associates Ltd
Tupelo 4448903, Mississippi 4436296 38801
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84000147 - Clinical Research Consultants
Kansas City 4393217, Missouri 4398678 64111
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84000377 - DCI-Rockhill
Kansas City 4393217, Missouri 4398678 64131
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84000328 - GSR Enterprises, Inc.
Lincoln 5072006, Nebraska 5073708 68510
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84000222 - Great Plains Health - Nephrology
North Platte 5697939, Nebraska 5073708 69101
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84000420 - DaVita Clinical Research - Henderson
Henderson 5505411, Nevada 5509151 89074
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84000337 - Kidney Specialists of Southern Nevada
Las Vegas 5506956, Nevada 5509151 89106
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84000148 - Sierra Nevada Specialty Care
Reno 5511077, Nevada 5509151 89511
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84000141 - Seacoast Kidney and Hypertension Specialists
Portsmouth 5091383, New Hampshire 5090174 03801
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84000436 - Hypertension & Nephrology Association
Eatontown 5097482, New Jersey 5101760 07724
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84000452 - New Jersey Kidney Care
Jersey City 5099836, New Jersey 5101760 07305
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84000184 - Mattoo & Bhat Medical Associates, P.C.
College Point 5113302, New York 5128638 11356
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84000393 - NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
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84000276 - Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
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84000191 - Metrolina Nephrology Associates, PA
Charlotte 4460243, North Carolina 4482348 28204
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84000150 - Durham Nephrology Associates, PA
Durham 4464368, North Carolina 4482348 27704
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84000232 - East Carolina University
Greenville 4469160, North Carolina 4482348 27858
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84000410 - North Carolina Nephrology, PA
Raleigh 4487042, North Carolina 4482348 27610
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84000548 - HNC Dialysis, Ltd.
Columbus 4509177, Ohio 5165418 43215
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84000234 - Northeast Clinical Research Center, LLC
Bethlehem 5180225, Pennsylvania 6254927 18017
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84000192 - Columbia Nephrology
Columbia 4575352, South Carolina 4597040 29203
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84000367 - Dialysis Clinic, Inc.
Spartanburg 4597200, South Carolina 4597040 29301
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84000229 - DaVita Clinical Research
Spartanburg 4597200, South Carolina 4597040 29306
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84000547 - Southeast Renal Research Institute
Chattanooga 4612862, Tennessee 4662168 37404
Contact:
Trial Information Contact
423-826-8003
dbunten@nephassociates.com

84000361 - Dialysis Clinic Inc - University Nephology
Knoxville 4634946, Tennessee 4662168 37920
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84000180 - Knoxville Kidney Center PLLC
Knoxville 4634946, Tennessee 4662168 37923
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84000451 - Cussimanio Research Group LLC
Austin 4671654, Texas 4736286 78751
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84000438 - Research Management, Inc.
Austin 4671654, Texas 4736286 78758
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84000549 - MW Clinical Research Center
Beaumont 4672989, Texas 4736286 77701
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84000457 - US Renal Care
Dallas 4684888, Texas 4736286 75237
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84000354 - Davita Clinical Research
El Paso 5520993, Texas 4736286 79925
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84000421 - DaVita Clinical Research - Horizon
El Paso 5520993, Texas 4736286 79935
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84000458 - Fort Worth Renal Group
Fort Worth 4691930, Texas 4736286 76110
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84000649 - Clinical Research Strategies
Houston 4699066, Texas 4736286 77030
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84000350 - DaVita Clinical Research
Houston 4699066, Texas 4736286 77054
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84000498 - DaVita Clinical Research
Houston 4699066, Texas 4736286 77054
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84000598 - Aqua Research Institute
Houston 4699066, Texas 4736286 77058
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84000450 - Houston Medical Research Institute, LLC
Houston 4699066, Texas 4736286 77074
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84000360 - Clinical Research Strategies, Inc.
Houston 4699066, Texas 4736286 77090
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84000196 - Southwest Houston Research
Houston 4699066, Texas 4736286 77099
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84000634 - Prime Clinical Research, Inc.
Mansfield 4709013, Texas 4736286 76063
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84000373 - Gamma Medical Research, Inc.
McAllen 4709796, Texas 4736286 78503
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84000324 - National Institute of Clinical Research, Inc.
San Antonio 4726206, Texas 4736286 78204
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84000351 - DaVita Clinical Research
San Antonio 4726206, Texas 4736286 78229
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84000419 - Davita Clinical Research
San Antonio 4726206, Texas 4736286 78251
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84000553 - DCR-San Antonio Stone Oak
San Antonio 4726206, Texas 4736286 78258
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84000339 - DaVita Clinical Research North Houston
Shenandoah 4728287, Texas 4736286 77384
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84000660 - Medrasa Clinical Research
Sherman 4728328, Texas 4736286 75092
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84000551 - Renal Research of Montgomery County
The Woodlands 4736476, Texas 4736286 77384
Contact:
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84000535 - DCR-Norfolk Great Bridge
Chesapeake 4752186, Virginia 6254928 23320
Contact:
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757-636-0220
brandy.clayton@davita.com

84000424 - Nephrology Associates of Northern Virginia Inc
Fairfax 4758023, Virginia 6254928 22033
Contact:
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703-961-0488
musirah.khan@nanvonline.com

84000138 - Peninsula Kidney Associates
Hampton 4762894, Virginia 6254928 23666
Contact:
Trial Information Contact
757-637-7848
ykireeva@pen-kid.com

84000156 - Tidewater Kidney Specialists
Norfolk 4776222, Virginia 6254928 23502
Contact:
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757-374-7186
gladys.caro-espinal@davita.com

84000336 - Nephrology and Hypertension Associates
Bluefield 4799622, West Virginia 4826850 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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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.

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