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
Status: Recruiting
Location: See all (534) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- 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
Locations
United States
Alabama
Nephrology of North Alabama
RECRUITING
Decatur
Nephrology Consultants, LLC
RECRUITING
Huntsville
DaVita Clinical Research Montgomery
RECRUITING
Montgomery
Arizona
AKDHC Medical
RECRUITING
Glendale
Kidney Disease Medical Group
RECRUITING
Glendale
AKDHC Medical
RECRUITING
Phoenix
AKDHC Medical
RECRUITING
Tucson
Southern Arizona VA Health Care System
RECRUITING
Tucson
California
National Institute of Clinical Research
RECRUITING
Bakersfield
Amicis Research Center
RECRUITING
Beverly Hills
California Institute of Renal Research
RECRUITING
Chula Vista
The Medical Research Group, Inc.
RECRUITING
Fresno
Davita Fullerton Dialysis Center
RECRUITING
Fullerton
National Institute of Clinical Research, Inc.
RECRUITING
Fullerton
National Institute of Clinical Research
RECRUITING
Garden Grove
National Institute of Clinical Research, Inc.
RECRUITING
Garden Grove
St. Jude Medical Center
RECRUITING
Garden Grove
Kidney Disease Medical Group
RECRUITING
Glendale
Sherman Medical Group, Inc
RECRUITING
Glendale
Renal Consultants Medical Group
RECRUITING
Granada Hills
Balboa Research
RECRUITING
La Jolla
California Institute of Renal Research
RECRUITING
La Mesa
Southern California Medical Research Center
RECRUITING
La Palma
Academic Medical Research Institute
RECRUITING
Los Angeles
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
DaVita Carabello Dialysis Center
SUSPENDED
Los Angeles
National Institute of Clinical Research, Inc.
RECRUITING
Los Angeles
Renal Medical Associates/NARI
RECRUITING
Lynwood
Amicis Research Center
RECRUITING
Northridge
FORMAT Medical Research
RECRUITING
Oxnard
National Nephrology Alliance Research - Riverside
RECRUITING
Riverside
Van Buren Dialysis Center
RECRUITING
Riverside
Central Coast Nephrology Medical Corp
RECRUITING
Salinas
California Institute of Renal Research
RECRUITING
San Diego
California Institute of Renal Research
SUSPENDED
San Diego
North America Research Institute
RECRUITING
San Dimas
Satellite Healthcare
SUSPENDED
San Jose
Nephrology Educational Services
RECRUITING
Tarzana
Valiance Clinical Research
RECRUITING
Tarzana
Amicis Research Center
RECRUITING
Vacaville
DaVita Vista Del Sol Dialysis
RECRUITING
Victorville
National Institute of Clinical Research, Inc
RECRUITING
Victorville
Colorado
Western Nephrology
RECRUITING
Arvada
Colorado Kidney Care
RECRUITING
Denver
Kidney Associates of Colorado, P.C.
RECRUITING
Denver
Connecticut
Greater Hartford Nephrology, LLC
RECRUITING
Bloomfield
Nephrology and Hypertension Associates PC
RECRUITING
Middlebury
Delaware
Nephrology Associates (Delaware)
RECRUITING
Newark
Florida
- Boca Raton Regional - Research Physicians Network Alliance
RECRUITING
Boca Raton
Nova Clinical Research, LLC
RECRUITING
Bradenton
Access Research Institute
RECRUITING
Brooksville
Horizon Research Group LLC
RECRUITING
Coral Gables
South Florida Nephrology Group, PA
RECRUITING
Coral Springs
Family First Medical Research Center
RECRUITING
Hialeah Gardens
Advanced Medical Research Group
RECRUITING
Hollywood
Elixia Pines
RECRUITING
Hollywood
Royal Research, Corp
RECRUITING
Hollywood
South Florida Research Institute
RECRUITING
Lauderdale Lakes
South Florida Research Organization LLC
RECRUITING
Medley
Aviva Health Sciences
RECRUITING
Miami
Iconic Clinical Research Center
RECRUITING
Miami
Kidney and Hypertension Specialists of Miami
RECRUITING
Miami
Nephrology Associates of South Miami
RECRUITING
Miami
Total Research Group, LLC
RECRUITING
Miami
Floridian Clinical Research
RECRUITING
Miami Lakes
Elixia Central Florida
RECRUITING
Orlando
Infigo Clinical Research LLC
RECRUITING
Sanford
Genesis Clinical Research
SUSPENDED
Tampa
Florida Kidney Specialists
RECRUITING
Temple Terrace
Florida Premier Research Institute
RECRUITING
Winter Park
Georgia
Southwest Georgia Nephrology Clinic
RECRUITING
Albany
Coastal Medical Research, LLC
RECRUITING
Brunswick
Renal Associates LLC
RECRUITING
Columbus
National Clinical Trials
RECRUITING
Cordele
American Clinical Trials
RECRUITING
Douglasville
Georgia Nephrology
RECRUITING
Lawrenceville
Atekha Nephrology Clinic LLC
COMPLETED
Statesboro
Iowa
Dunes Clinical Research LLC
RECRUITING
Sioux City
Indiana
NANI Research
RECRUITING
Fort Wayne
Nephrology Physician's LLC
RECRUITING
Mishawaka
Kansas
Kansas Nephrology Physicians, PA
RECRUITING
Wichita
Kentucky
Nephrology Associates of Kentuckiana, PSC
RECRUITING
Louisville
Louisiana
Renal Associates of Baton Rouge
RECRUITING
Baton Rouge
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Michigan
Paragon Health, Inc
RECRUITING
Kalamazoo
Michigan Kidney Consultants, PC
RECRUITING
Pontiac
St. Clair Nephrology Research
RECRUITING
Roseville
Center for Advanced Kidney Research, PLC
RECRUITING
Saint Clair Shores
Minnesota
DCR Edina
RECRUITING
Minneapolis
DCR Edina
COMPLETED
Minneapolis
Minneapolis VA Health Care System
RECRUITING
Minneapolis
Missouri
Clinical Research Consultants
RECRUITING
Kansas City
DCI-Rockhill
RECRUITING
Kansas City
Kansas City VA Medical Center
RECRUITING
Kansas City
Mississippi
Southwest Mississippi Nephrology PLLC
COMPLETED
Brookhaven
Nephrology Associates, PC
RECRUITING
Columbus
- Nephrology and Hypertension Associates Ltd
RECRUITING
Tupelo
North Carolina
Metrolina Nephrology Associates, PA
RECRUITING
Charlotte
Duke Translational Medicine Institute
RECRUITING
Durham
Durham Nephrology Associates, PA
RECRUITING
Durham
East Carolina University
RECRUITING
Greenville
Eastern Nephrology Associates, PLLC
RECRUITING
Kinston
North Carolina Nephrology, PA
RECRUITING
Raleigh
Nephrology Associates of the Carolinas
RECRUITING
Shelby
Nebraska
GSR Enterprises, Inc.
RECRUITING
Lincoln
Great Plains Health - Nephrology
RECRUITING
North Platte
New Hampshire
Seacoast Kidney and Hypertension Specialists
RECRUITING
Portsmouth
New Jersey
Hypertension & Nephrology Association
RECRUITING
Eatontown
New Jersey Kidney Care
RECRUITING
Jersey City
New Mexico
U.S. Renal Care - Gallup
RECRUITING
Gallup
Nevada
DaVita Clinical Research - Henderson
RECRUITING
Henderson
Kidney Specialists of Southern Nevada
RECRUITING
Las Vegas
Sierra Nevada Specialty Care
RECRUITING
Reno
New York
Albany Medical College Committee of Research Involving Human Subjects
RECRUITING
Albany
SUNY Downstate Medical Center Brooklyn
RECRUITING
Brooklyn
Mattoo & Bhat Medical Associates, P.C.
RECRUITING
College Point
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Albert Einstein College of Medicine - Montefiore Medical Center
RECRUITING
The Bronx
DaVita Clinic Research Bronx
COMPLETED
The Bronx
James J Peters VA Medical Center
RECRUITING
The Bronx
Ohio
HNC Dialysis, Ltd.
RECRUITING
Columbus
Pennsylvania
Northeast Clinical Research Center, LLC
RECRUITING
Bethlehem
Clinical Renal Associates, LTD
RECRUITING
Exton
Rhode Island
Lifespan Clinical Research
RECRUITING
East Providence
South Carolina
Columbia Nephrology
RECRUITING
Columbia
DaVita Clinical Research
RECRUITING
Spartanburg
Dialysis Clinic, Inc.
RECRUITING
Spartanburg
Tennessee
Southeast Renal Research Institute
RECRUITING
Chattanooga
Dialysis Clinic Inc - University Nephology
RECRUITING
Knoxville
Knoxville Kidney Center PLLC
RECRUITING
Knoxville
Lt. Col. Luke Weathers, Jr. VA Medical Center
RECRUITING
Memphis
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Cussimanio Research Group LLC
RECRUITING
Austin
Research Management, Inc.
RECRUITING
Austin
MW Clinical Research Center
RECRUITING
Beaumont
Dallas Nephrology Associates
RECRUITING
Dallas
Dallas V.A. Medical Center
RECRUITING
Dallas
US Renal Care
RECRUITING
Dallas
Davita Clinical Research
RECRUITING
El Paso
DaVita Clinical Research - Horizon
RECRUITING
El Paso
Fort Worth Renal Group
RECRUITING
Fort Worth
Aqua Research Institute
RECRUITING
Houston
Clinical Research Strategies
RECRUITING
Houston
Clinical Research Strategies, Inc.
RECRUITING
Houston
DaVita Clinical Research
RECRUITING
Houston
Gulf Coast Clinical Research
RECRUITING
Houston
Houston Medical Research Institute, LLC
RECRUITING
Houston
Southwest Houston Research
RECRUITING
Houston
Laguna Clinical Research Associates, LLC
RECRUITING
Laredo
Prime Clinical Research, Inc.
RECRUITING
Mansfield
Gamma Medical Research, Inc.
RECRUITING
Mcallen
Davita Clinical Research
RECRUITING
San Antonio
DaVita Clinical Research
RECRUITING
San Antonio
DCR-San Antonio Stone Oak
RECRUITING
San Antonio
National Institute of Clinical Research, Inc.
RECRUITING
San Antonio
DaVita Clinical Research North Houston
RECRUITING
Shenandoah
Medrasa Clinical Research
RECRUITING
Sherman
Renal Research of Montgomery County
RECRUITING
The Woodlands
Virginia
DCR-Norfolk Great Bridge
RECRUITING
Chesapeake
Nephrology Associates of Northern Virginia Inc
RECRUITING
Fairfax
Peninsula Kidney Associates
RECRUITING
Hampton
Tidewater Kidney Specialists
RECRUITING
Norfolk
West Virginia
Nephrology and Hypertension Associates
RECRUITING
Bluefield
Other Locations
Argentina
FME Lomas de Zamora
RECRUITING
Banfield
FME Avellaneda
RECRUITING
Buenos Aires
FME Mansilla
RECRUITING
Buenos Aires
Instituto de Trasplante De La Ciudad Autonoma De Buenos Aires
RECRUITING
Buenos Aires
FME Cemic Saavedra
RECRUITING
Ciudad Autonoma
CEREHA
RECRUITING
Ciudad De Buenos Aires
Fresenius Medical Care - Ciudad Evita
RECRUITING
Ciudad Evita
Clinica Privada Velez Sarsfield
RECRUITING
Córdoba
FME Formosa
RECRUITING
Formosa
STR Hurlingham SRL
RECRUITING
Hurlingham
Nextdial S.A.
RECRUITING
Mar Del Plata
Fresenius Medical Care - Nostri Centri Dialisi - Moron
RECRUITING
Morón
Instituto Medico de la Fundacion de Estudios Clínicos
RECRUITING
Rosario
Fresenius Tucumán
RECRUITING
San Miguel De Tucumán
Australia
Wide Bay Hospital and Health Service
RECRUITING
Bundaberg
Cairns Hospital
RECRUITING
Cairns
Monash Medical Centre
RECRUITING
Clayton
Austin Hospital
RECRUITING
Heidelberg
Liverpool Hospital
RECRUITING
Liverpool
Fiona Stanley Hospital
RECRUITING
Murdoch
Sunshine Coast University Private Hospital
RECRUITING
Nambour
Sunshine Coast University Private Hospital
SUSPENDED
Nambour
Royal Melbourne Hospital
RECRUITING
Parkville
Royal North Shore Hospital (RNSH)
RECRUITING
Saint Leonards
Gold Coast University Hospital
RECRUITING
Southport
Sunshine Hospital
RECRUITING
St Albans
Concord Repatriation General Hospital
RECRUITING
Sydney
Fraser Coast Renal Service, Hervey Bay Hospital
RECRUITING
Urraween
Sydney Adventist Hospital
RECRUITING
Wahroonga
Westmead Hospital
RECRUITING
Westmead
Wollongong Renal Unit
RECRUITING
Wollongong
Princess Alexandra Hospital
SUSPENDED
Woolloongabba
Austria
Wiener Gesundheitsverbund - Klinik Hietzing
RECRUITING
Vienna
Belgium
Onze-Lieve-Vrouwziekenhuis VZW
RECRUITING
Aalst
Imelda Ziekenhuis
RECRUITING
Bonheiden
Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie Curie
RECRUITING
Charleroi
AZ Sint-Lucas
SUSPENDED
Ghent
Centre Hospitalier Universitaire de Tivoli
RECRUITING
La Louvière
Jan Yperman Ziekenhuis
RECRUITING
Leper
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
CHR de la Citadelle
RECRUITING
Liège
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
RECRUITING
Roeselare
VITAZ, Department Nierziekten & Dialyse
RECRUITING
Sint-niklaas
Brazil
NUPEC-Nucleo de Pesquisa Clinica
RECRUITING
Belo Horizonte
Santa Casa de Misericordia de Belo Horizonte
RECRUITING
Belo Horizonte
Hospital Universitário Walter Cantídio (Fortaleza)
RECRUITING
Fortaleza
Fundacao Pro Rim de Santa Catarina
RECRUITING
Joinville
Clipem - Clínica o Pesquisa Endocrinológica de Maringá
RECRUITING
Maringá
Hospital de Clinicas de Passo Fundo
RECRUITING
Passo Fundo
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital São Lucas da PUCRS
RECRUITING
Porto Alegre
Irmandade Santa Casa de Misericordia de Porto Alegre
RECRUITING
Porto Alegre
CEDOES - Centro de Diagnostico e Pesquisa
RECRUITING
Praia Do Canto
SERVIÇO DE NEFROLOGIA DE RIBEIRÃO Preto (SENERP)
RECRUITING
Ribeirão Preto
Universidade de Sao Paulo (USP)-Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto (HCFMRP)
RECRUITING
Ribeirão Preto
Clinica Senhor do Bonfim Ltda (CSB) - Monte Serrat
RECRUITING
Salvador
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
Hospital 9 de Julho
RECRUITING
São Paulo
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
RECRUITING
São Paulo
Hospital do Rim e Hipertensão
RECRUITING
São Paulo
Hospital Santa Marcelina
RECRUITING
São Paulo
Bulgaria
Multiprofile Hospital for Active Treatment - Dobrich AD
RECRUITING
Dobrich
Multiprofile Hospital For Active Treatment Dr Tota Venkova
RECRUITING
Gabrovo
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz - LOM EOOD
RECRUITING
Lom
Dialysis Centre Montana
RECRUITING
Montana
UMHAT Plovdiv
RECRUITING
Plovdiv
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
RECRUITING
Plovdiv
Multiprofile Hospital for Active Treatment Dr. Ivan Seliminski - Sliven AD
RECRUITING
Sliven
Medical Center - Smolyan OOD
RECRUITING
Smolyan
UMHAT Aleksandrovska
RECRUITING
Sofia
University Hospital for Active Treatment Tsaritsa Joanna ISUL EAD
RECRUITING
Sofia
Dialysis Center VIA DIAL OOD
RECRUITING
Stara Zagora
UMHAT Prof. Dr. Stoyan Kirkovich
RECRUITING
Stara Zagora
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Queen Elizabeth II Health Sciences Centre
RECRUITING
Halifax
St. Josephs Healthcare Hamilton
RECRUITING
Hamilton
Kingston Health Sciences Centre
RECRUITING
Kingston
London Health Sciences Centre - University Hospital
RECRUITING
London
Hospital Charles Lemoyne
RECRUITING
Longueuil
CHUM - Centre hospitalier de l'Universite de Montreal
RECRUITING
Montreal
Hôpital du Sacré-Cœur-de-Montréal
RECRUITING
Montreal
Maisonneuve-Rosemont Hospital
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
Lakeridge Health Oshawa
RECRUITING
Oshawa
The Ottawa Hospital Research Institute
RECRUITING
Ottawa
Ciussse-Chus
RECRUITING
Sherbrooke
St. Michaels Hospital
RECRUITING
Toronto
St Paul Hospital
RECRUITING
Vancouver
Seven Oaks Hospital
RECRUITING
Winnipeg
China
Inner Mongolia Baotou City Central Hospital (Baotou Central Hospital)
RECRUITING
Baotou Shi
Peking University People's Hospital
RECRUITING
Beijeing
Beijing Miyun Hospital
RECRUITING
Beijing
Beijing Tsinghua Chang Gung Hospital
RECRUITING
Beijing
China Rehabilitation Research Center (Beijing Boai Hospital)
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The Affiliated Zhongshan Hospital (Dalian Railroad Hospital)
RECRUITING
Dalian
People's Hospital of Deyang
RECRUITING
Deyang Shi
Dongguan People's Hospital
RECRUITING
Dongguan
The Fifth Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Anhui Medical University-The Second Hospital
RECRUITING
Hefei
The First Hospital of Jiaxing
RECRUITING
Jiaxing
Gansu Provincial People's Hospital
RECRUITING
Lanzhou
Jiangsu Province Hospital /The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Lanzhou
Henan University of Science and Technology-The First Affiliated Hospital
RECRUITING
Luoyang Shi
The Third Hospital of Mianyang
RECRUITING
Mianyang
Nanchang University - The First Affiliated Hospital
RECRUITING
Nanchang
Jiangsu Province Hospital of Chinese Medicine
RECRUITING
Nanjing
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
The People's Hospital Guangxi Zhuang of Autonomous Region
RECRUITING
Nanning
Southern Medical University - Jiangxi Pingxiang People's Hospital
RECRUITING
Pingxiang
Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji Hospital
RECRUITING
Shanghai
Shanghai First People's Hospital
RECRUITING
Shanghai Shi
Shenzhen Second People's Hospital (Shenzhen University First Affiliated Hospital)
RECRUITING
Shenzhen
Shijiazhuang People's Hospital
RECRUITING
Shijiazhuang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Second Hospital of Shanxi Medical University
RECRUITING
Taiyuan
Tianjin People's Hospital
RECRUITING
Tianjin
Huazhong University of Science and Technology - Tongji Medical College - The Central Hospital of Wuhan (Wuhan Second Hospital)
RECRUITING
Wuhan
Renmin Hospital of Wuhan University/Hubei General Hospital
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
Zhongshan Hospital Xiamen University
RECRUITING
Xiamen
Yan'an University Xianyang Hospital
RECRUITING
Xianyang
Xinxiang City First People's Hospital
RECRUITING
Xinxiang
Northern Jiangsu People's Hospital
RECRUITING
Yangzhou
Yibin Second People's Hospital
RECRUITING
Yibin
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Denmark
Aalborg Universitetshospital
RECRUITING
Aalborg
Herlev Hospital
RECRUITING
Herlev
Gødstrup Hospital
RECRUITING
Herning
Trail Nation: Nordsjællands Hospital
RECRUITING
Hillerød
Trial Nation: Holbæk Sygehus
RECRUITING
Holbæk
France
CHU Amiens - Nephrology Dialysi Transplantation Department
RECRUITING
Amiens
CHU de Saint-Étienne - Hôpital Nord
RECRUITING
Aura
Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital de la Cavale Blanche
RECRUITING
Brest
CHU de Caen
RECRUITING
Caen
Polyclinique Saint Come - Centre de Dialyse
RECRUITING
Compiègne
Fondation Charles Mion AIDER Santé
RECRUITING
Grabels
Hopital Prive La Louviere
RECRUITING
Lille
CHU de Limoges
RECRUITING
Limoges
Hopitaux Universitaires de Marseille
RECRUITING
Marseille
Centre Hospitalier Universitaire Montpellier - Hôpital Lapeyronie
RECRUITING
Montpellier
CHE de Nice - Pasteur Hospital
RECRUITING
Nice
CHU de Nimes - Hopital Universitaire Caremeau
RECRUITING
Nîmes
AURA Paris - Plaisance
RECRUITING
Paris
Hopital Pitie-Salpetriere
RECRUITING
Paris
Centre Hospitalier Universitaire (CHU) de Reims - Hopital Maison Blanche
RECRUITING
Reims
AURA St Quen Dialysis centre
RECRUITING
Saint-ouen
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
RECRUITING
Strasbourg
CHU Rangueil
RECRUITING
Toulouse
Germany
Charite-Universitatsmedizin Berlin
RECRUITING
Berlin
Nierenzentrum Bad König
RECRUITING
Hessen
Westpfalz Klinikum GmbH
RECRUITING
Kaiserslautern
UKSH - Universitatsklinik Schleswig-Holstein
SUSPENDED
Kiel
Kuratorium fuer Dialyse und Nierentransplantation e.V. - KfH-Nierenzentrum - St. Georg
RECRUITING
Leipzig
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
RECRUITING
Mainz
Nephrologisches Zentrum Villingen-Schwenningen
RECRUITING
Villingen-schwenningen
Greece
University Hospital of Alexandroupolis
RECRUITING
Alexandroupoli
General Hospital of Arta
RECRUITING
Arta
University General Hospital of Heraklion
RECRUITING
Crete
Mesogeios Nephrology Center
RECRUITING
Haidari
General Hospital of Ioannina G. Hatzikosta
RECRUITING
Ioannina
University General Hospital of Ioannina
RECRUITING
Ioannina
Nephrological Clinic University Hospital, University of Thessaly
RECRUITING
Larissa
Mitera Hospital, Hemodialysis Unit
RECRUITING
Marousi
General Hospital of Ptolemaida
RECRUITING
Ptolemaida
University Hospital of Patras
RECRUITING
Rio
AHEPA Univ. Hospital, Medical School, Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
Aristotle University, Hippokration
RECRUITING
Thessaloniki
General Hospital of Thessaloniki, Agios Pavlos
RECRUITING
Thessaloniki
Nephrology Department G. Papanikolaou General Hospital
RECRUITING
Thessaloniki
Papageorgiou General Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Princess Margaret Hospital
RECRUITING
Ho Man Tin
Queen Mary Hospital Hong Kong
RECRUITING
Pok Fu Lam
Yan Chai Hospital
RECRUITING
Tsuen Wan
Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz
RECRUITING
Kaposvár
B. Braun Avitum - 14. Dialízisközpont Kistarcs
RECRUITING
Kistarcsa
Israel
Emek Medical Center
RECRUITING
Afula
Barzilai Medical Center
RECRUITING
Ashkelon
Carmel Medical Center
RECRUITING
Haifa
Edith Wolfson Medical Center
RECRUITING
Holon
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Chaim Sheba Medical Center (Sheba Tel-Hashomer Medical Center )
RECRUITING
Ramat Gan
Kaplan Medical Center
RECRUITING
Rehovot
Ziv Medical Center
RECRUITING
Safed
Ichilov Hospital-Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Medical Research & Development Fund for Health Services, PORIYA Hospital
RECRUITING
Tiberias
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
RECRUITING
Bologna
ASST degli Spedali Civili di Brescia
RECRUITING
Brescia
Azienda Ospedaliera Brotzu
RECRUITING
Cagliari
Azienda Ospedaliera Sant'Anna e San Sebastiano di Caserta
RECRUITING
Caserta
AOU Policlinico G Rodolico - San Marco - Presidio Ospedaliero ospedale San Marco
RECRUITING
Catania
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna
RECRUITING
Ferrara
Ospedale Santa Maria Annunziata
RECRUITING
Florence
A. O. -Universitaria Ospedali Riuniti di Foggia Farmacia Osp
RECRUITING
Foggia
IRCCS Az. Osp. Universitaria San Martino- IST
RECRUITING
Genova
Vito Fazzi Hospital in Lecce
RECRUITING
Lecce
ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
RECRUITING
Lecco
Università degli Studi di Messina
RECRUITING
Messina
ASST Great Metropolitan Hospital Niguarda
RECRUITING
Milan
ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
RECRUITING
Naples
Ospedale Maggiore di Novara
RECRUITING
Novara
ICS Maugeri S.p.A. SB; Università di Pavia; Fondazione Salvatore Maugeri IRCCS
RECRUITING
Pavia
University of Verona
RECRUITING
Peschiera Del Garda
AUSL Piacenza Hospital-Unit Nephrology Dialysis, Dept of Medicine
RECRUITING
Piacenza
Azienda Ospedaliero Universitaria Pisana - Ospedale di Cisanello - Stabilimento Ospedaliero di Cisanello
RECRUITING
Pisana
Ospedale Santo Stefan
RECRUITING
Prato
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
RECRUITING
Reggio Calabria
Rimini Hospital
RECRUITING
Rimini
Policlinico A. Gemelli Universitario
RECRUITING
Roma
Azienda Unita Sanitaria Locale (USL) Roma 3 (AUSL RM 3) - Presidio Ospedaliero Giovan Battista Grassi
RECRUITING
Rome
Sandro Pertini Hospital
RECRUITING
Rome
Ospedale Casa Sollievo della Sofferenza (CSS)
RECRUITING
San Giovanni Rotondo
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
RECRUITING
Verona
Japan
Matsunami General Hospital
RECRUITING
Hashima-gun
Ishikiriseiki Hospital
RECRUITING
Higashiosaka-shi
NHO Hiroshimanishi Medical Center
RECRUITING
Hiroshima
Miki Internal Medicine Urology Clinic
RECRUITING
Hokkaido
Daiyukai Daiichi Hospital
RECRUITING
Ichinomiya-shi
Tokyo Medical University Ibaraki Medical Center
RECRUITING
Inashiki-gun
Ueyama Hospital
RECRUITING
Kagoshima
Ueyama Jin Clinic
RECRUITING
Kagoshima
Shonan Kamakura General Hospital
RECRUITING
Kamakura-shi
National Hospital Organization Kanazawa Medical Center
RECRUITING
Kanazawa
Kokura Memorial Hospital
RECRUITING
Kitakyushu-shi
Steel Memorial Yawata Hospital
RECRUITING
Kitakyushu-shi
Kurume University Hospital
RECRUITING
Kurume
St. Mary's Hospital
RECRUITING
Kurume-shi
Omi freai Hospital
RECRUITING
Kusatsu-shi
Rakuwakai Otowa Kinen Hospital
RECRUITING
Kyoto
Joumou Ohashi Clinic
RECRUITING
Maebashi
Maebashi Hirosegawa Clinic
RECRUITING
Maebashi
Matsubara Tokushukai Hospital
RECRUITING
Matsubara-shi
Nagaoka Red-Cross Hospital
RECRUITING
Nagaoka-shi
Chubu Rosai Hospital
RECRUITING
Nagoya
Daido Hospital
RECRUITING
Nagoya
Ogaki Tokushukai Hospital
RECRUITING
Ogaki-shi
Omihachiman Community Medical Center - Kidney Center
RECRUITING
Ōmihachiman
Oguranaika Jin Cinic
RECRUITING
Oyama-shi
Ibaraki Seinan Medical Center Hospital
RECRUITING
Sakaimachi
Teine Urological Clinic
RECRUITING
Sapporo
Tokyo Womens Med University
RECRUITING
Shinjuku-ku
Kurosawa Hospital
RECRUITING
Takasaki-shi
Kikuchi Medical Clinic
RECRUITING
Tsukuba
St.Hill Hospital
RECRUITING
Ube-shi
Juntendo University Urayasu Hospital
RECRUITING
Urayasu-shi
Yamagata Tokushukai Hospital
RECRUITING
Yamagata
Bosei Kannai Clinic
RECRUITING
Yokohama
Sanin Rosai Hospital
RECRUITING
Yonago-shi
Malaysia
Hospital Raja Permaisuri Bainun, Ipoh
RECRUITING
Ipoh
Queen Elizabeth Hospital
RECRUITING
Kota Kinabalu
University Malaya Medical Centre
RECRUITING
Lembah Pantai
Hospital Kuala Lumpur
RECRUITING
Pejabat Pakar
Seberang Jaya Hospital
RECRUITING
Perai
Seri Manjung Hospital
RECRUITING
Perak
Norway
Vestre Viken HF - Drammen Sykehus (Sykehuset Buskerud)
RECRUITING
Drammen
Sykehuset Østfold Kalnes
RECRUITING
Grålum
Sykehuset Telemark
RECRUITING
Skien
Poland
Davita Stacja Dializ w Brodnicy
RECRUITING
Brodnica
Slaski Uniwersytet Medyczny (SUM) w Katowicach
RECRUITING
Katowice
Davita-Łęczna
RECRUITING
Łęczna
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodz, Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny Nr. 1 im. Norberta Barlickiego
RECRUITING
Lodz
DaVita Stacja Dializ
RECRUITING
Pszczyna
Powiatowy Szpital Specjalistyczny w Stalowej Woli
RECRUITING
Stalowa Wola
Samodzielny Publiczny Szpital Kliniczny Nr. 2 Pomorski Uniwersytet Medyczny w Szczecinie
RECRUITING
Szczecin
Diaverum - NZOZ Tczewie
RECRUITING
Tczew
DaVita Stacja Dializ
RECRUITING
Warsaw
Wojskowy Instytut Medyczny (WIM) - Centralny Szpital Kliniczny (CSK) MON - Klinika Chorob Wewnetrznych
RECRUITING
Warsaw
Portugal
Unidade Local de Saúde de Braga, E. P. E.
RECRUITING
Braga
Caledial - Centro de Hemodiálise de Gaia
RECRUITING
Canelas-v.n.gaia
NephroCare Carregado
RECRUITING
Carregado
Nephrocare Faro
RECRUITING
Faro
Centro Hospitalar e Universitário de Lisboa Centra
RECRUITING
Lisbon
Fresenius Medical Care - NephroCare - Unidade de Hemodialise do Restelo
RECRUITING
Lisbon
Unidade Local de Saúde de Loures -Odivelas, E. P. E.
RECRUITING
Loures
Unidade Local de Saúde de São José, E. P. E.
RECRUITING
Oeiras
Fresenius NephroCare
RECRUITING
Porto
Unidade Local de Saúde de Santo António, E. P. E.
RECRUITING
Porto
Unidade Local de Saúde do Médio Tejo, E. P. E.
RECRUITING
Torres Novas
Unidade Local de Saúde do Estuário do Tejo, E. P. E.
RECRUITING
Vila Franca De Xira
Puerto Rico
Legacy Senior Living
RECRUITING
Humacao
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang-si
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Gangnam Severance Hospital
RECRUITING
Gangnam-gu
National Health Insurance Service - Ilsan Hospital
RECRUITING
Goyang-si
Hanyang University Guri Hospital
RECRUITING
Guri-si
Konkuk University Medical Center
RECRUITING
Gwangju
SMG - SNU Boramae Medical Center
RECRUITING
Ilsan-gu
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University
RECRUITING
Seoul
Yonsei University - Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Romania
Centrul de Dializa Fresenius NephroCare Brasov
RECRUITING
Brasov
Centrul de Dializa Fresenius NephroCare Bucaresti
RECRUITING
Bucharest
Centrul de Nefrologie si Dializa Diaverum Fundeni
RECRUITING
Bucharest
Centrul de Nefrologie si Dializa DIAVERUM Sema Parc
RECRUITING
Bucharest
Centrul De Nefrologie si Dializa DIAVERUM SPLAI
RECRUITING
Bucharest
Fundeni Clinical Institute
RECRUITING
Bucharest
SC International Healthcare Systems SA - IHS Sf. Ioan Dialysis Center
RECRUITING
Bucharest
Centrul de Dializa Fresenius NephroCare Cluj
RECRUITING
Cluj-napoca
Centrul de Dializa Fresenius NephroCare Constanta
RECRUITING
Constanța
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta (Emergency Clinic Hospital Constanta)
RECRUITING
Constanța
Centrul de Nefrologie si Dializa Diaverum Craiova
RECRUITING
Craiova
Spitalul Judetean de Urgenta Deva
RECRUITING
Deva
Spitalul Clinic -Dr. C.I. Parhon - Iasi
RECRUITING
Iași
Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea
RECRUITING
Oradea
Centrul de Dializa Fresenius NephroCare Ploiesti
RECRUITING
Ploieşti
Spital Judetean de Urgenta Satu Mare
RECRUITING
Satu Mare
Centrul Medical de Nefrologie si Dializa Diaverum Targu Mures
RECRUITING
Târgu Mureş
Slovakia
Nefrologicka ambulancia Levice - FMC dialyzacne sluzby, s.r.o.
RECRUITING
Levice
LC-REN s.r.o.
RECRUITING
Lučenec
Biodial, s.r.o.
RECRUITING
Púchov
Spain
Centro de dialisis Alcobendas
RECRUITING
Alcobendas
Hospital Universitari de Bellvitge (IDIBELL)
RECRUITING
Barcelona
Hospital Universitario Valle de Hebron
RECRUITING
Barcelona
University Hospital Reina Sofía
RECRUITING
Córdoba
Hospital Universitari de Girona Dr Josep Trueta, (Avitum)
RECRUITING
Girona
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Universidad de Alcala (UAH)
RECRUITING
Guadalajara
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario de La Princesa
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Príncipe de Asturias
RECRUITING
Madrid
Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital de Manises
RECRUITING
Manises
Hospital Universitari Son Espases
RECRUITING
Palma De Mallorca
CHUS - H. Clinico U. de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen de la Macarena
RECRUITING
Seville
Fresenius Medical Care Centro de Diálisis Terrassa
RECRUITING
Terrassa
Centro Hospital Universitario Dr. Preset
RECRUITING
Valencia
Hospital Clinico Universitario - Valencia
RECRUITING
Valencia
Hospital Universitari i Politècnic La Fe
RECRUITING
Valencia
Sweden
Karolinska Huddinge
RECRUITING
Huddinge
Region Stockholm-SLSO
RECRUITING
Stockholm
Uppsala Universitet - Akademiska Sjukhuset
RECRUITING
Uppsala
Taiwan
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
Taipei Medical University Shuang Ho Hospital
RECRUITING
New Taipei City
Thailand
Maharat Nakhon Ratchasima Hospital
RECRUITING
Amphoe Mueang
Ramathibodi Hospital
RECRUITING
Bangkok
Chiang Mai University
RECRUITING
Chiang Mai
Turkey
Hacettepe University,Faculty of Medicine
RECRUITING
Ankara
Akdeniz University Medical Faculty Hospital
RECRUITING
Antalya
Ondokuz Mayis Üniversitesi
RECRUITING
Atakum
İstanbul Bakirköy Dr.Sadi Konuk Eğitim Araştirma Hastanesi
RECRUITING
Bakırköy
Ege University Hospital
RECRUITING
Bornova
Trakya Üniversitesi Tıp Fakültesi
RECRUITING
Edirne
Kocaeli University, Medical Faculty, Division of Nephrology
RECRUITING
İzmit
Kahramanmaras Sutcu Imam University - Tip Fakultesi (Kahramanmaras Sutcu Imam University Faculty of Medicine)
RECRUITING
Kahramanmaraş
Malatya Education and Research Hospital
RECRUITING
Yeşilyurt
United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Birmingham Heartlands Hospital (BHH)
RECRUITING
Birmingham
Bradford Teaching Hospitals NHS Foundation Trust
RECRUITING
Bradford
University Hospital Coventry and Warwickshire
RECRUITING
Coventry
University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
RECRUITING
Derby
Dorset County Hospital NHS Foundation Trust - Dorset County Hospital (DCH)
RECRUITING
Dorchester
Royal Liverpool University Hospital
RECRUITING
Liverpool
Hammersmith Hospital Imperial College Healthcare NHS Trust -Hammersmith Hospital - West London Renal and Transplant Centre
RECRUITING
London
King´s College NHS Trust
RECRUITING
London
St George's University Hospitals NHS Foundation Trust - St G
RECRUITING
London
William Harvey Research Institute ; Barts Health NHS Trust - The Royal London Hospital
RECRUITING
London
Altnagelvin Area Hospital
RECRUITING
Londonderry
Northern Care Alliance NHS Foundation Trust - Salford Royal NHS Foundation Trust-Salford Care Organisation
RECRUITING
Salford
The Shrewsbury and Telford Hospital NHS Trust (SaTH) - Royal Shrewsbury Hospital
RECRUITING
Shrewsbury
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
The Royal Wolverhampton NHS Trust - New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Trial Registration Coordinator
clinicaltrials@cslbehring.com
+1 610-878-4697
Time Frame
Start Date: 2022-10-21
Estimated Completion Date: 2029-09-27
Participants
Target number of participants: 2310
Treatments
Experimental: CSL300 (low dose)(Phase 2b)
Intravenous (IV) administration
Experimental: CSL300 (medium dose)(Phase 2b)
IV administration
Experimental: CSL300 (high dose)(Phase 2b)
IV administration
Placebo_comparator: Placebo (Phase 2b)
IV administration
Experimental: CSL300 (Phase 3)
IV administration
Placebo_comparator: Placebo (Phase 3)
IV administration
Related Therapeutic Areas
Sponsors
Leads: CSL Behring