Clinical trial NCT05485961: Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Official title: A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Atherosclerotic Cardiovascular Disease
End Stage Kidney Disease
Atherosclerotic Cardiovascular Disease in Patients With ESKD
Keywords: End Stage Kidney Disease (ESKD)
Myocardial infarction (MI)
Atherosclerotic cardiovascular disease (ASCVD)
Coronary artery disease
Peripheral artery disease
Diabetes
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2022-08-03
Enrollment: 2310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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
* 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

Primary outcomes:
measure: Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
timeFrame: Approximately 5 years
Secondary outcomes:
measure: Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)
timeFrame: Week 12
measure: Change from baseline in log-transformed hs-CRP (Phase 2b)
timeFrame: Baseline and up to 24 weeks
measure: Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in fibrinogen (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in albumin (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in Hepcidin (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in hemoglobin (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in iron (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Mean change from Baseline in ferritin (Phase 2b)
timeFrame: Baseline and up to 12 weeks
measure: Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)
timeFrame: Up to 24 weeks
measure: Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)
timeFrame: Up to 24 weeks
measure: Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)
timeFrame: Up to 24 weeks
measure: Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)
timeFrame: Up to 24 weeks
measure: Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)
timeFrame: Up to 32 weeks
measure: Mean change from Baseline in white blood cell (WBC) (Phase 2b)
timeFrame: Up to 12 weeks
measure: Mean change from Baseline in neutrophils (Phase 2b)
timeFrame: Up to 12 weeks
measure: Mean change from Baseline in platelets (Phase 2b)
timeFrame: Up to 12 weeks
measure: Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)
timeFrame: Up to 12 weeks
measure: Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)
timeFrame: Up to 12 weeks
measure: Mean change from Baseline in total bilirubin (Phase 2b)
timeFrame: Up to 12 weeks
measure: Mean change from Baseline in lipid panel (Phase 2b)
timeFrame: Up to 12 weeks
measure: Titer of confirmed antibodies specific to CSL300 (Phase 2b)
timeFrame: Up to 12 weeks
measure: Time to first occurrence of all-cause death or MI (Phase 3)
timeFrame: Approximately 5 years
measure: Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)
timeFrame: Approximately 5 years
measure: Time to first occurrence of CV death (Phase 3)
timeFrame: Approximately 5 years
measure: Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)
timeFrame: Approximately 5 years
measure: Time to first occurrence of all-cause death (Phase 3)
timeFrame: Approximately 5 years
measure: Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)
timeFrame: Approximately 5 years
measure: Total number of CV hospitalizations (Phase 3)
timeFrame: Approximately 5 years
measure: Total number of HF hospitalizations and urgent visits (Phase 3)
timeFrame: Approximately 5 years
measure: Total number of hospitalizations (Phase 3)
timeFrame: Approximately 5 years
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: 84000149 - Nephrology Consultants, LLC
state: Alabama
city: Montgomery
country: United States
facility: 84000340 - DaVita Clinical Research Montgomery
state: Alabama
city: Glendale
country: United States
facility: 84000552 - AKDHC Medical
state: Arizona
city: Glendale
country: United States
facility: 84000178 - Kidney Disease Medical Group
state: Arizona
city: Phoenix
country: United States
facility: 84000231 - AKDHC Medical
state: Arizona
city: Tucson
country: United States
facility: 84000286 - AKDHC Medical
state: Arizona
city: Bakersfield
country: United States
facility: 84000145 - National Institute of Clinical Research
state: California
city: Bakersfield
country: United States
facility: 84000151 - National Institute of Clinical Research
state: California
city: Beverly Hills
country: United States
facility: 84000277 - Amicis Research Center
state: California
city: Chula Vista
country: United States
facility: 84000241 - California Institute of Renal Research
state: California
city: Fullerton
country: United States
facility: 84000462 - Davita Fullerton Dialysis Center
state: California
city: Fullerton
country: United States
facility: 84000574 - National Institute of Clinical Research, Inc.
state: California
city: Garden Grove
country: United States
facility: 84000464 - St. Jude Medical Center
state: California
city: Garden Grove
country: United States
facility: 84000573 - National Institute of Clinical Research, Inc.
state: California
city: Garden Grove
country: United States
facility: 84000152 - National Institute of Clinical Research
state: California
city: Glendale
country: United States
facility: 84000531 - Sherman Medical Group, Inc
state: California
city: Glendale
country: United States
facility: 84000230 - Kidney Disease Medical Group
state: California
city: Granada Hills
country: United States
facility: 84000379 - Renal Consultants Medical Group
state: California
city: La Mesa
country: United States
facility: 84000221 - California Institute of Renal Research
state: California
city: La Mesa
country: United States
facility: 84000235 - California Institute of Renal Research
state: California
city: La Palma
country: United States
facility: 84000198 - Southern California Medical Research Center
state: California
city: La Palma
country: United States
facility: 84000467 - Southern California Medical Research Center
state: California
city: Los Angeles
country: United States
facility: 84000329 - Academic Medical Research Institute
state: California
city: Los Angeles
country: United States
facility: 84000439 - National Institute of Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: 84000158 - DaVita Carabello Dialysis Center
state: California
city: Lynwood
country: United States
facility: 84000175 - Renal Medical Associates/NARI
state: California
city: Northridge
country: United States
facility: 84000279 - Amicis Research Center
state: California
city: Oxnard
country: United States
facility: 84000533 - FORMAT Medical Research
state: California
city: Riverside
country: United States
facility: 84000331 - Van Buren Dialysis Center
state: California
city: Riverside
country: United States
facility: 84000228 - National Nephrology Alliance Research - Riverside
state: California
city: Salinas
country: United States
facility: 84000492 - Central Coast Nephrology Medical Corp
state: California
city: San Diego
country: United States
facility: 84000238 - California Institute of Renal Research
state: California
city: San Diego
country: United States
facility: 84000143 - California Institute of Renal Research
state: California
city: San Dimas
country: United States
facility: 84000330 - North America Research Institute
state: California
city: San Dimas
country: United States
facility: 84000341 - North America Research Institute
state: California
city: San Jose
country: United States
facility: 84000281 - Satellite Healthcare
state: California
city: Tarzana
country: United States
facility: 84000440 - Nephrology Educational Services
state: California
city: Tarzana
country: United States
facility: 84000536 - Valiance Clinical Research
state: California
city: Vacaville
country: United States
facility: 84000278 - Amicis Research Center
state: California
city: Victorville
country: United States
facility: 84000323 - National Institute of Clinical Research, Inc
state: California
city: Victorville
country: United States
facility: 84000174 - DaVita Vista Del Sol Dialysis
state: California
city: Denver
country: United States
facility: 84000454 - Kidney Associates of Colorado, P.C.
state: Colorado
city: Denver
country: United States
facility: 84000223 - Colorado Kidney Care
state: Colorado
city: Bloomfield
country: United States
facility: 84000176 - Greater Hartford Nephrology, LLC
state: Connecticut
city: Middlebury
country: United States
facility: 84000173 - Nephrology and Hypertension Associates PC
state: Connecticut
city: Newark
country: United States
facility: 84000494 - Nephrology Associates (Delaware)
state: Delaware
city: Boca Raton
country: United States
facility: 84000441 - Boca Raton Regional - Research Physicians Network Alliance
state: Florida
city: Coral Gables
country: United States
facility: 84000193 - Horizon Research Group LLC
state: Florida
city: Coral Springs
country: United States
facility: 84000443 - South Florida Nephrology Group, PA
state: Florida
city: Hialeah Gardens
country: United States
facility: 84000597 - Family First Medical Research Center
state: Florida
city: Hollywood
country: United States
facility: 84000650 - Advanced Medical Research Group
state: Florida
city: Hollywood
country: United States
facility: 84000406 - Elixia Pines
state: Florida
city: Lauderdale Lakes
country: United States
facility: 84000140 -South Florida Research Institute
state: Florida
city: Medley
country: United States
facility: 84000599 - South Florida Research Organization LLC
state: Florida
city: Miami Lakes
country: United States
facility: 84000527 - Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: 84000495 - Total Research Group, LLC
state: Florida
city: Miami
country: United States
facility: 84000663 - Iconic Clinical Research Center
state: Florida
city: Miami
country: United States
facility: 84000362 - Kidney and Hypertension Specialists of Miami
state: Florida
city: Miami
country: United States
facility: 84000182 - Nephrology Associates of South Miami
state: Florida
city: Orlando
country: United States
facility: 84000400 - Elixia Central Florida
state: Florida
city: Tampa
country: United States
facility: 84000139 - Genesis Clinical Research
state: Florida
city: Temple Terrace
country: United States
facility: 84000532 - Florida Kidney Specialists
state: Florida
city: Winter Park
country: United States
facility: 84000426 - Florida Premier Research Institute
state: Florida
city: Albany
country: United States
facility: 84000366 - Southwest Georgia Nephrology Clinic
state: Georgia
city: Brunswick
country: United States
facility: 84000326 - Coastal Medical Research, LLC
state: Georgia
city: Columbus
country: United States
facility: 84000157 - Renal Associates LLC
state: Georgia
city: Douglasville
country: United States
facility: 84000327 - American Clinical Trials
state: Georgia
city: Statesboro
country: United States
facility: 84000194 - Atekha Nephrology Clinic LLC
state: Georgia
city: Mishawaka
country: United States
facility: 84000453 - Nephrology Physician's LLC
state: Indiana
city: Sioux City
country: United States
facility: 84000534 - Dunes Clinical Research LLC
state: Iowa
city: Wichita
country: United States
facility: 84000374 - Kansas Nephrology Physicians, PA
state: Kansas
city: Louisville
country: United States
facility: 84000554 - Nephrology Associates of Kentuckiana, PSC
state: Kentucky
city: Baton Rouge
country: United States
facility: 84000550 - Renal Associates of Baton Rouge
state: Louisiana
city: Kalamazoo
country: United States
facility: 84000465 - Paragon Health, Inc
state: Michigan
city: Pontiac
country: United States
facility: 84000408 - Michigan Kidney Consultants, PC
state: Michigan
city: Roseville
country: United States
facility: 84000171 - St. Clair Nephrology Research
state: Michigan
city: Saint Clair Shores
country: United States
facility: 84000237 - Center for Advanced Kidney Research, PLC
state: Michigan
city: Minneapolis
country: United States
facility: 84000146 - DCR Edina
state: Minnesota
city: Minneapolis
country: United States
facility: 84000338 - DCR Edina
state: Minnesota
city: Brookhaven
country: United States
facility: 84000225 - Southwest Mississippi Nephrology PLLC
state: Mississippi
city: Columbus
country: United States
facility: 84000153 - Nephrology Associates, PC
state: Mississippi
city: Tupelo
country: United States
facility: 84000144 - Nephrology and Hypertension Associates Ltd
state: Mississippi
city: Kansas City
country: United States
facility: 84000147 - Clinical Research Consultants
state: Missouri
city: Kansas City
country: United States
facility: 84000377 - DCI-Rockhill
state: Missouri
city: Lincoln
country: United States
facility: 84000328 - GSR Enterprises, Inc.
state: Nebraska
city: North Platte
country: United States
facility: 84000222 - Great Plains Health - Nephrology
state: Nebraska
city: Henderson
country: United States
facility: 84000420 - DaVita Clinical Research - Henderson
state: Nevada
city: Las Vegas
country: United States
facility: 84000337 - Kidney Specialists of Southern Nevada
state: Nevada
city: Reno
country: United States
facility: 84000148 - Sierra Nevada Specialty Care
state: Nevada
city: Portsmouth
country: United States
facility: 84000141 - Seacoast Kidney and Hypertension Specialists
state: New Hampshire
city: Eatontown
country: United States
facility: 84000436 - Hypertension & Nephrology Association
state: New Jersey
city: Jersey City
country: United States
facility: 84000452 - New Jersey Kidney Care
state: New Jersey
city: Bronx
country: United States
facility: 84000155 - DaVita Clinic Research Bronx
state: New York
city: Bronx
country: United States
facility: 84000276 - Albert Einstein College of Medicine - Montefiore Medical Center
state: New York
city: College Point
country: United States
facility: 84000184 - Mattoo & Bhat Medical Associates, P.C.
state: New York
city: Mineola
country: United States
facility: 84000393 - NYU Langone Hospital - Long Island
state: New York
city: Charlotte
country: United States
facility: 84000191 - Metrolina Nephrology Associates, PA
state: North Carolina
city: Durham
country: United States
facility: 84000150 - Durham Nephrology Associates, PA
state: North Carolina
city: Greenville
country: United States
facility: 84000232 - East Carolina University
state: North Carolina
city: Raleigh
country: United States
facility: 84000410 - North Carolina Nephrology, PA
state: North Carolina
city: Columbus
country: United States
facility: 84000548 - HNC Dialysis, Ltd.
state: Ohio
city: Bethlehem
country: United States
facility: 84000234 - Northeast Clinical Research Center, LLC
state: Pennsylvania
city: Columbia
country: United States
facility: 84000192 - Columbia Nephrology
state: South Carolina
city: Spartanburg
country: United States
facility: 84000229 - DaVita Clinical Research
state: South Carolina
city: Knoxville
country: United States
facility: 84000361 - Dialysis Clinic Inc - University Nephology
state: Tennessee
city: Knoxville
country: United States
facility: 84000180 - Knoxville Kidney Center PLLC
state: Tennessee
city: Austin
country: United States
facility: 84000451 - Cussimanio Research Group LLC
state: Texas
city: Austin
country: United States
facility: 84000438 - Research Management, Inc.
state: Texas
city: Beaumont
country: United States
facility: 84000549 - MW Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: 84000457 - US Renal Care
state: Texas
city: El Paso
country: United States
facility: 84000354 - Davita Clinical Research
state: Texas
city: El Paso
country: United States
facility: 84000421 - DaVita Clinical Research - Horizon
state: Texas
city: Fort Worth
country: United States
facility: 84000458 - Fort Worth Renal Group
state: Texas
city: Houston
country: United States
facility: 84000350 - DaVita Clinical Research
state: Texas
city: Houston
country: United States
facility: 84000498 - DaVita Clinical Research
state: Texas
city: Houston
country: United States
facility: 84000598 - Aqua Research Institute
state: Texas
city: Houston
country: United States
facility: 84000450 - Houston Medical Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: 84000360 - Clinical Research Strategies, Inc.
state: Texas
city: Houston
country: United States
facility: 84000196 - Southwest Houston Research
state: Texas
city: Mansfield
country: United States
facility: 84000634 - Prime Clinical Research, Inc.
state: Texas
city: McAllen
country: United States
facility: 84000373 - Gamma Medical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: 84000324 - National Institute of Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: 84000351 - DaVita Clinical Research
state: Texas
city: San Antonio
country: United States
facility: 84000419 - Davita Clinical Research
state: Texas
city: San Antonio
country: United States
facility: 84000553 - DCR-San Antonio Stone Oak
state: Texas
city: Shenandoah
country: United States
facility: 84000339 - DaVita Clinical Research North Houston
state: Texas
city: Chesapeake
country: United States
facility: 84000535 - DCR-Norfolk Great Bridge
state: Virginia
city: Fairfax
country: United States
facility: 84000424 - Nephrology Associates of Northern Virginia Inc
state: Virginia
city: Hampton
country: United States
facility: 84000138 - Peninsula Kidney Associates
state: Virginia
city: Norfolk
country: United States
facility: 84000156 - Tidewater Kidney Specialists
state: Virginia
city: Bluefield
country: United States
facility: 84000336 - Nephrology and Hypertension Associates
state: West Virginia
city: Saint Leonards
country: Australia
facility: 03600023 - Royal North Shore Hospital (RNSH)
state: New South Wales
city: Sydney
country: Australia
facility: 03600017 - Concord Repatriation General Hospital
state: New South Wales
city: Cairns
country: Australia
facility: 03600037 - Cairns Hospital
state: Queensland
city: Nambour
country: Australia
facility: 03600021 - Sunshine Coast University Private Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: 03600014 - Princess Alexandra Hospital
state: Queensland
city: Clayton
country: Australia
facility: 03600013 - Monash Medical Centre
state: Victoria
city: St Albans
country: Australia
facility: 03600011 - Sunshine Hospital
state: Victoria
city: St Albans
country: Australia
facility: 03600011 - Sunshine Hospital
state: Victoria
city: Murdoch
country: Australia
facility: 03600050 - Fiona Stanley Hospital
city: Nambour
country: Australia
facility: 03600021 - Sunshine Coast University Private Hospital
city: Southport
country: Australia
facility: 03600020 - Gold Coast University Hospital
city: Westmead
country: Australia
facility: 03600012 - Westmead Hospital
city: Wollongong
country: Australia
facility: 03600048 - Wollongong Renal Unit
city: Aalst
country: Belgium
facility: 05600011 - Onze-Lieve-Vrouwziekenhuis VZW
city: Aalst
country: Belgium
facility: 05600011 - Onze-Lieve-Vrouwziekenhuis VZW
city: Bonheiden
country: Belgium
facility: 05600005 - Imelda Ziekenhuis
city: Gent
country: Belgium
facility: 05600004 - AZ Sint-Lucas
city: La Louvière
country: Belgium
facility: 05600013 - Centre Hospitalier Universitaire de Tivoli
city: Leuven
country: Belgium
facility: 05600012 - Universitair Ziekenhuis Leuven
city: Liège
country: Belgium
facility: 05600003 - CHR de la Citadelle
city: Liège
country: Belgium
facility: 05600003 - CHR de la Citadelle
city: Roeselare
country: Belgium
facility: 05600018 - AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
city: Lom
country: Bulgaria
facility: 10000002 - Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
city: Smolyan
country: Bulgaria
facility: 10000001 - Medical Center - Smolyan OOD
city: Stara Zagora
country: Bulgaria
facility: 10000005 - Dialysis Center VIA DIAL OOD
city: Edmonton
country: Canada
facility: 12400008 - University of Alberta Hospital
state: Alberta
city: Halifax
country: Canada
facility: 12400021 - Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: 12400026 - St. Josephs Healthcare Hamilton
state: Ontario
city: Kingston
country: Canada
facility: 12400009 - Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: 12400030 - London Health Sciences Centre - University Hospital
state: Ontario
city: Oshawa
country: Canada
facility: 12400024 - Lakeridge Health Oshawa
state: Ontario
city: Montreal
country: Canada
facility: 12400023 - McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: 12400015 - Hôpital du Sacré-Cœur-de-Montréal
state: Quebec
city: Montréal
country: Canada
facility: 12400014 - Maisonneuve-Rosemont Hospital
city: Montréal
country: Canada
facility: 12400031 - CHUM - Centre hospitalier de l'Universite de Montreal
city: Toronto
country: Canada
facility: 12400032 - St. Michaels Hospital
city: Beijing
country: China
facility: 15600014 - Peking University First Hospital
city: Zhenjiang City
country: China
facility: 15600026 - Affiliated Hospital of Jiangsu University
city: Aalborg
country: Denmark
facility: 20800009 - Aalborg Universitetshospital
city: Herlev
country: Denmark
facility: 20800010 - Herlev Hospital
city: Herning
country: Denmark
facility: 20800008 - Gødstrup Hospital
city: Hillerød
country: Denmark
facility: 20800011 - Trail Nation: Nordsjællands Hospital
city: Amiens
country: France
facility: 25000011 - CHU Amiens - Nephrology Dialysi Transplantation Department
city: Aura
country: France
facility: 25000014 - CHU de Saint-Étienne - Hôpital Nord
city: Brest
country: France
facility: 25000027 - Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
city: Caen
country: France
facility: 25000013 - CHU de Caen
city: Limoges Cedex
country: France
facility: 25000033 - CHU de Limoges
city: Montpellier
country: France
facility: 25000018 - Centre Hospitalier Universitaire Montpellier - Hôpital Lapeyronie
city: Paris
country: France
facility: 25000025 - AURA Paris - Plaisance
city: Saint-Ouen
country: France
facility: 25000016 - AURA St Quen Dialysis centre
city: Strasbourg
country: France
facility: 25000029 - Hôpitaux Universitaires de Strasbourg - Hôpital Civil
city: Toulouse
country: France
facility: 25000012 - CHU Rangueil
city: Berlin
country: Germany
facility: 27600047 - Charite-Universitatsmedizin Berlin
city: Hessen
country: Germany
facility: 27600041 - Nierenzentrum Bad König
city: Kaiserslautern
country: Germany
facility: 27600039 - Westpfalz Klinikum GmbH
city: Kiel
country: Germany
facility: 27600022 - UKSH - Universitatsklinik Schleswig-Holstein
city: Mainz
country: Germany
facility: 27600040 - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Villingen-Schwenningen
country: Germany
facility: 27600020 - Nephrologisches Zentrum Villingen-Schwenningen
city: Villingen-Schwenningen
country: Germany
facility: 27600020 - Nephrologisches Zentrum Villingen-Schwenningen
city: Alexandroupolis
country: Greece
facility: 30000015 - University Hospital of Alexandroupolis
city: Crete
country: Greece
facility: 30000012 - University General Hospital of Heraklion
city: Ioánnina
country: Greece
facility: 30000004 - University General Hospital of Ioannina
city: Ioánnina
country: Greece
facility: 30000002 - General Hospital of Ioannina G. Hatzikosta
city: Larissa
country: Greece
facility: 30000014 - Nephrological Clinic University Hospital, University of Thessaly
city: Rio
country: Greece
facility: 30000008 - University Hospital of Patras
city: Thessaloniki
country: Greece
facility: 30000005 - Aristotle University, Hippokration
city: Thessaloníki
country: Greece
facility: 30000003 - AHEPA Univ. Hospital, Medical School, Aristotle University of Thessaloniki
city: Thessaloníki
country: Greece
facility: 30000006 - General Hospital of Thessaloniki, Agios Pavlos
city: Thessaloníki
country: Greece
facility: 30000009 - Papageorgiou General Hospital of Thessaloniki
city: Thessaloníki
country: Greece
facility: 30000011 - Nephrology Department G. Papanikolaou General Hospital
city: Árta
country: Greece
facility: 30000016 - General Hospital of Arta
city: Kistarcsa
country: Hungary
facility: 34800012 - B. Braun Avitum - 14. Dialízisközpont Kistarcs
city: Haifa
country: Israel
facility: 37600008 - Carmel Medical Center
city: H̱olon
country: Israel
facility: 37600012 - Edith Wolfson Medical Center
city: Petah Tikva
country: Israel
facility: 37600010 - Rabin Medical Center
city: Ramat Gan
country: Israel
facility: 37600011 - Chaim Sheba Medical Center (Sheba Tel-Hashomer Medical Center )
city: Tel Aviv
country: Israel
facility: 37600009 - Ichilov Hospital-Tel-Aviv Sourasky Medical Center
city: Tiberias
country: Israel
facility: 37600002 - Medical Research & Development Fund for Health Services, PORIYA Hospital
city: Zefat
country: Israel
facility: 37600013 - Ziv Medical Center
city: Brescia
country: Italy
facility: 38000025 - ASST degli Spedali Civili di Brescia
city: Caserta
country: Italy
facility: 38000031 - Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta
city: Florence
country: Italy
facility: 38000074 - Ospedale Santa Maria Annunziata
city: Foggia
country: Italy
facility: 38000027 - A. O. -Universitaria Ospedali Riuniti di Foggia Farmacia Osp
city: Lecco
country: Italy
facility: 38000024 - ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
city: Messina
country: Italy
facility: 38000029 - Università degli Studi di Messina
city: Milano
country: Italy
facility: 38000023 - IRCCS Ospedale San Raffaele
city: Novara
country: Italy
facility: 38000069 - Ospedale Maggiore di Novara
city: Pavia
country: Italy
facility: 38000019 - ICS Maugeri S.p.A. SB; Università di Pavia; Fondazione Salvatore Maugeri IRCCS
city: Peschiera Del Garda
country: Italy
facility: 38000026 - University of Verona
city: Prato
country: Italy
facility: 38000032 - Ospedale Santo Stefan
city: Rimini
country: Italy
facility: 38000067 - Rimini Hospital
city: San Giovanni Rotondo
country: Italy
facility: 38000016 - Ospedale Casa Sollievo della Sofferenza (CSS)
city: Verona
country: Italy
facility: 38000020 - Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
city: Ichinomiya-shi
country: Japan
facility: 39200053 - Daiyukai Daiichi Hospital
state: Aichi
city: Urayasu-shi
country: Japan
facility: 39200044 - Juntendo University Urayasu Hospital
state: Chiba-ken
city: Kitakyushu-shi
country: Japan
facility: 39200046 - Steel Memorial Yawata Hospital
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: 39200048 - Maebashi Hirosegawa Clinic
state: Gunma
city: Maebashi-shi
country: Japan
facility: 39200049 - Joumou Ohashi Clinic
state: Gunma
city: Sapporo-shi
country: Japan
facility: 39200045 - Teine Urological Clinic
state: Hokkaido
city: Kusatsu-shi
country: Japan
facility: 39200054 - Omi freai Hospital
state: Shiga
city: Shinjuku-Ku
country: Japan
facility: 39200027 - Tokyo Womens Med University
state: Tokyo
city: Hashima-gun
country: Japan
facility: 39200042 - Matsunami General Hospital
city: Higashiosaka-shi
country: Japan
facility: 39200041 - Ishikiriseiki Hospital
city: Hokkaido
country: Japan
facility: 39200055 - Miki Internal Medicine Urology Clinic
city: Inashiki-gun
country: Japan
facility: 39200033 - Tokyo Medical University Ibaraki Medical Center
city: Kagoshima-shi
country: Japan
facility: 39200043 - Ueyama Hospital
city: Kurume-shi
country: Japan
facility: 39200038 - St. Mary's Hospital
city: Kurume
country: Japan
facility: 39200021 - Kurume University Hospital
city: Kyoto-Shi
country: Japan
facility: 39200028 - Rakuwakai Otowa Kinen Hospital
city: Nagaoka-Shi
country: Japan
facility: 39200037 - Nagaoka Red-Cross Hospital
city: Nagoya-shi
country: Japan
facility: 39200035 - Daido Hospital
city: Nagoya
country: Japan
facility: 39200020 - Chubu Rosai Hospital
city: Omihachiman
country: Japan
facility: 39200026 - Omihachiman Community Medical Center - Kidney Center
city: Oyama-shi
country: Japan
facility: 39200032 - Oguranaika Jin Cinic
city: Sakaimachi
country: Japan
facility: 39200029 - Ibaraki Seinan Medical Center Hospital
city: Takasaki-Shi
country: Japan
facility: 39200031 - Kurosawa Hospital
city: Tsukuba-shi
country: Japan
facility: 39200034 - Kikuchi Medical Clinic
city: Ube-shi
country: Japan
facility: 39200030 - St.Hill Hospital
city: Yokohama-shi
country: Japan
facility: 39200051 - Bosei Kannai Clinic
city: Yonago-shi
country: Japan
facility: 39200036 - Sanin Rosai Hospital
city: Ilsan-gu
country: Korea, Republic of
facility: 41000002 - SMG - SNU Boramae Medical Center
state: Seoul
city: Anyang-si
country: Korea, Republic of
facility: 41000006 - Hallym University Sacred Heart Hospital
city: Daegu
country: Korea, Republic of
facility: 41000004 - Keimyung University Dongsan Medical Center
city: Gangnam-gu
country: Korea, Republic of
facility: 41000001 - Gangnam Severance Hospital
city: Goyang-si
country: Korea, Republic of
facility: 41000009 - National Health Insurance Service - Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: 41000008 - Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: 41000005 - Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: 41000012 - Severance Hospital, Yonsei University
city: Wonju-si
country: Korea, Republic of
facility: 41000007 - Yonsei University - Wonju Severance Christian Hospital
city: Braga
country: Portugal
facility: 62000011 - Unidade Local de Saúde de Braga, E. P. E.
city: Loures
country: Portugal
facility: 62000010 - Unidade Local de Saúde de Loures -Odivelas, E. P. E.
city: Oeiras
country: Portugal
facility: 62000009 - Unidade Local de Saúde de São José, E. P. E.
city: Porto
country: Portugal
facility: 62000005 - Unidade Local de Saúde de Santo António, E. P. E.
city: Bucharest
country: Romania
facility: 64200014 - SC International Healthcare Systems SA - IHS Sf. Ioan Dialysis Center
city: Bucuresti
country: Romania
facility: 64200024 - Fundeni Clinical Institute
city: Constanta
country: Romania
facility: 64200016 - Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta (Emergency Clinic Hospital Constanta)
city: Satu Mare
country: Romania
facility: 64200005 - Spital Judetean de Urgenta Satu Mare
city: Lleida
country: Spain
facility: 72400007 - Hospital Universitari Arnau de Vilanova
city: Uppsala
country: Sweden
facility: 75200001 - Uppsala Universitet - Akademiska Sjukhuset
city: Bradford
country: United Kingdom
facility: 82600027 - Bradford Teaching Hospitals NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: 82600023 - University Hospital Coventry and Warwickshire
city: Derby
country: United Kingdom
facility: 82600060 - University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
city: Liverpool
country: United Kingdom
facility: 82600024 - Royal Liverpool University Hospital
city: Londonderry
country: United Kingdom
facility: 82600028 - Altnagelvin Area Hospital
city: London
country: United Kingdom
facility: 82600034 - St George's University Hospitals NHS Foundation Trust - St G
city: Salford
country: United Kingdom
facility: 82600029 - Northern Care Alliance NHS Foundation Trust - Salford Royal NHS Foundation Trust-Salford Care Organisation
city: Stoke-on-Trent
country: United Kingdom
facility: 82600025 - Royal Stoke University Hospital
city: Wolverhampton
country: United Kingdom
facility: 82600049 - The Royal Wolverhampton NHS Trust - New Cross Hospital
Study officials:
affiliation: CSL Behring LLC
name: Study Director
role: STUDY_DIRECTOR
References: