Clinical trial NCT00773513: A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
Official title: A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 2825
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.


Eligibility criteria: Inclusion Criteria:

* Male or female participants with symptomatic anemia associated with CKD
* Participants with renal anemia who are not treated with an ESA:
* Anemia was defined as hemoglobin (Hb) concentration less than (\<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
* Participants with renal anemia who are on maintenance ESA therapy:
* If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
* Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
* Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent

Exclusion Criteria:

* Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
* Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
* History of hemoglobinopathy
* Anemia due to hemolysis
* Pure red cell aplasia
* High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
* Pregnancy or breast-feeding
* Women of childbearing potential without effective contraception
* Administration of another investigational drug within 1 month before screening or planned during the study period

Primary outcomes:
measure: Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First
timeFrame: Baseline up to approximately 8.5 years
Secondary outcomes:
measure: Time to All-Cause Mortality
timeFrame: Baseline up to approximately 8.5 years
measure: Time to Non-Fatal and Fatal Myocardial Infarction
timeFrame: Baseline up to approximately 8.5 years
measure: Time to Non-Fatal and Fatal Stroke
timeFrame: Baseline up to approximately 8.5 years
measure: Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
timeFrame: Baseline up to approximately 8.5 years
measure: Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
timeFrame: Baseline up to approximately 8.5 years
measure: Percentage of Participants With Gastrointestinal Bleeding
timeFrame: Baseline up to approximately 8.5 years
measure: Percentage of Participants With Thromboembolic Events
timeFrame: Baseline up to approximately 8.5 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Fresenius Medical Care Martinez
city: Buenos Aires
country: Argentina
facility: Fresenius Medical Care Morón
city: Buenos Aires
country: Argentina
facility: Fresenius Medical Care San Martin
city: Caba
country: Argentina
facility: Fresenuis Medical Care Mansilla
city: Gosford
country: Australia
facility: Gosford Hospital; Renal
state: New South Wales
city: Gosford
country: Australia
facility: Renal Research Dr Simon Roger
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Hospital; Renal Services
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital Department of Pharmacology & Therapeutics
state: Queensland
city: Adelaide
country: Australia
facility: ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS
state: South Australia
city: Launceston
country: Australia
facility: Launceston General Hospital; Diabetes and Renal Research Unit
state: Tasmania
city: Clayton
country: Australia
facility: Monash Medical Centre; Renal Transplant Unit
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital; Nephrology
state: Western Australia
city: Brussel
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Wilgenstraat)
city: Juiz de Fora
country: Brazil
facility: Centro Mineiro de Pesquisa - CMIP
state: MG
city: Curitiba
country: Brazil
facility: PUCPR
state: PR
city: Rio de Janeiro
country: Brazil
facility: Hospital Univ. Pedro Ernesto - Hupe; Nefrologia
state: RJ
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Beneficencia Portuguesa de Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP
state: SP
city: Sao Paulo
country: Brazil
facility: Clinica de Medicina Interna e Nefrologia (CMIN)
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP; Nefrologia
state: SP
city: Sorocaba
country: Brazil
facility: Instituto de Hemodialise Sorocaba
state: SP
city: Karlovac
country: Croatia
facility: General Hospital Karlovac; Dept of Haemodialysis
city: Osijek
country: Croatia
facility: Clinical Hospital Osijek; Dept of Haemodialysis
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka; Dialysis
city: Slavonski Brod
country: Croatia
facility: General Hospital Josip Bencevic; Department of Haemodialysis
city: Split
country: Croatia
facility: Clinical Hospital Split; Dialysis
city: Zadar
country: Croatia
facility: General Hospital Zadar; Dialysis
city: Zagreb
country: Croatia
facility: Klinicki Bolnicki Centar Zagreb; Dialysis
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika
city: Ostrava
country: Czechia
facility: Faculty Hospital; Dialysis Unit
city: Praha 6
country: Czechia
facility: Nemocnice Strahov; Interni Oddeleni-Strahov
city: Praha
country: Czechia
facility: Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie
city: Annonay
country: France
facility: Centre Hospitalier; Hemodialyse
city: Bordeaux
country: France
facility: Hopital Pellegrin; Departement Nephrologie
city: Boulogne
country: France
facility: Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse
city: Brest
country: France
facility: Hopital La Cavale Blanche; Nephrologie
city: Colmar
country: France
facility: Hopital Louis Pasteur; Nephrologie - Hemodialyse
city: La Garenne-Colombes
country: France
facility: Clinique Lambert; Service de Néphrologie dialyse
city: Limoges
country: France
facility: Chu Dupuytren; Nephrologie-Hemodialyse
city: Lyon
country: France
facility: Aural
city: Lyon
country: France
facility: Hopital Edouard-Herriot; Nephrologie - Hemodialyse
city: Macon
country: France
facility: Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12
city: Nantes
country: France
facility: Service de Nephrologie & D'Immunologie; Clinique
city: Nimes
country: France
facility: Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse
city: Paris
country: France
facility: Aura - Centre Henri Kunt Ziger
city: Saint Herblain
country: France
facility: Hopital Laennec; Echo
city: Salouel
country: France
facility: Hopital Sud ; Nephrologie Hemodialyse
city: Strasbourg
country: France
facility: Hopital Civil; Nephrologie Clinique Medicale B
city: Toulouse
country: France
facility: Hopital Rangueil; Nephrologie Hemodialyse
city: Valenciennes
country: France
facility: Ch De Valenciennes; Nephrologie
city: Alsfeld
country: Germany
facility: Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst
city: Bad Hersfeld
country: Germany
facility: KFH Nierenzentrum Bad Hersfeld; Nephrologie
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
city: Demmin
country: Germany
facility: Dialysepraxis Dr. med. Uwe Kraatz
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Deutschland GmbH
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
city: Gießen
country: Germany
facility: Georg-Haas-Dialysezentrum der PHV
city: Hamburg
country: Germany
facility: Nephrologische Schwerpunktpraxis; Hamburg Barmbek
city: Hann. Münden
country: Germany
facility: Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen
city: Heidelberg
country: Germany
facility: Uniklinikum Heidelberg
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
city: Kiel
country: Germany
facility: UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV
city: München
country: Germany
facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum
city: Oberschleissheim
country: Germany
facility: KFH Nierenzentrum Oberschleissheim
city: Rostock
country: Germany
facility: Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.
city: Schwandorf
country: Germany
facility: Praxis Dr.med. Joachim Leicht
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie
city: Alexandroupolis
country: Greece
facility: Uni Hospital of Alexandroupoli; Nephrology Dept.
city: Athens
country: Greece
facility: Laiko General Hospital; Nephrology Div.
city: Ioannina
country: Greece
facility: Uni Hospital of Ioannina; Nephrology Dept.
city: Larissa
country: Greece
facility: Univeristy Hospital of Larissa; Nephrology
city: Thessaloniki
country: Greece
facility: Hippokratio Hospital; Nefrology
city: Petach Tikva
country: Israel
facility: Rabin MC- Belinson campus
city: Petah Tikva
country: Israel
facility: Rabin MC- Hasharon campus
city: Ramat-Gan
country: Israel
facility: Sheba MC; Nephrology
city: Tel Aviv
country: Israel
facility: Sourasky MC; Dept. of Nephrology
city: Zrifin
country: Israel
facility: Assaf-Harofeh MC; Nephrology
city: Carpi
country: Italy
facility: Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi
state: Emilia-Romagna
city: Imola
country: Italy
facility: Ospedale Civile; Servizio Di Nefrologia E Dialisi
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi
state: Emilia-Romagna
city: Parma
country: Italy
facility: Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: Ospedale Civile; Divisione de Nefrologia E Dialisi
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi
state: Emilia-Romagna
city: Roma
country: Italy
facility: Universita' Di Tor Vergata; Clinica Nefrologia Dialisi
state: Lazio
city: Genova
country: Italy
facility: A.O. Universitaria S. Martino Di Genova; Nefrologia
state: Liguria
city: Bollate
country: Italy
facility: Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi
state: Lombardia
city: Lecco
country: Italy
facility: ASST DI LECCO; Nefrologia e Dialisi
state: Lombardia
city: Milano
country: Italy
facility: Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi
state: Lombardia
city: Milano
country: Italy
facility: ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi
state: Lombardia
city: Milano
country: Italy
facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi
state: Lombardia
city: S Fermo Della Battaglia
country: Italy
facility: ASST LARIANA; Divisione di Nefrologia e Dialisi
state: Lombardia
city: Pesaro
country: Italy
facility: Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi
state: Marche
city: Acireale
country: Italy
facility: Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi
state: Sicilia
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia
state: Sicilia
city: Messina
country: Italy
facility: A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi
state: Sicilia
city: Lodi
country: Italy
facility: Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi
state: Toscana
city: Prato
country: Italy
facility: Nuovo Ospedale Di Prato
state: Toscana
city: Castelfranco
country: Italy
facility: Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi
state: Veneto
city: Cona (FE)
country: Italy
facility: Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi
state: Veneto
city: Conegliano
country: Italy
facility: P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi
state: Veneto
city: Padova
country: Italy
facility: Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi
state: Veneto
city: Rovigo
country: Italy
facility: Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi
state: Veneto
city: Treviso
country: Italy
facility: A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti
state: Veneto
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center; Nephrology Department
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinic, Nephrology Center
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre; Division of Nephrology, Department of Medicine
state: FED. Territory OF Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur; Department of Medicine
city: Selangor
country: Malaysia
facility: Selayang Hospital; Dept of Medicine
city: Cuernavaca
country: Mexico
facility: Investigación Nefrológica S.C.
state: Morelos
city: Panama
country: Panama
facility: Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal
city: CEBU City
country: Philippines
facility: Cebu Doctors University Hospital
city: Quezon City
country: Philippines
facility: National Kidney and Transplant Institute
city: Bydgoszcz
country: Poland
facility: Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych
city: Ciechanow
country: Poland
facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny
city: Dabrowa Tarnowska
country: Poland
facility: Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn
city: Gorlice
country: Poland
facility: NZOZ Stacja Dializ Hand-Prod w Gorlicach
city: Jaslo
country: Poland
facility: Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle
city: Limanowa
country: Poland
facility: NZOZ Stacja Dializ Hand-Prod w Limanowej
city: Pabianice
country: Poland
facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach
city: Poznan
country: Poland
facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu
city: Rzeszow
country: Poland
facility: Stacja Dializ NZOZ Centrum Medyczne MEDYK
city: Sandomierz
country: Poland
facility: Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu
city: Skierniewice
country: Poland
facility: Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice
city: Stalowa Wola
country: Poland
facility: Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii
city: Walbrzych
country: Poland
facility: Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny
city: Zamosc
country: Poland
facility: S.P. Szpital Wojewodzki im. Papieza Jana Pawla II
city: Sankt-peterburg
country: Russian Federation
facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
state: Leningrad
city: Saint-Petersburg
country: Russian Federation
facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF
city: St.Petersburg
country: Russian Federation
facility: St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"
city: St.Petersburg
country: Russian Federation
facility: St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia; Clinic of Urology
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Belgrade
country: Serbia
facility: Zemun Hospital; Nephrology
city: NIS
country: Serbia
facility: Clinical Center Nis; Clinic for Nephrology and Hemodialysis
city: Novi Sad
country: Serbia
facility: Clinical Center Voivodina; Clinic for Immunology and Nephrology
city: Singapore
country: Singapore
facility: National University Hospital; Dept of Medicine
city: Singapore
country: Singapore
facility: Singapore General Hospital; Renal Medicine
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital; Department of Renal Medicine
city: Vitoria
country: Spain
facility: Hospital Txagorritxu; Servicio de Nefrologia
state: Alava
city: Almería
country: Spain
facility: Complejo Hospitalario Torrecardenas; Servicio de Nefrologia
state: Almeria
city: Leganes
country: Spain
facility: Hospital Severo Ochoa; Servicio de Nefrologia
state: Madrid
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Infanta Sofia; Servico de Nefrologia
state: Madrid
city: Pamplona
country: Spain
facility: Hospital de Navarra; Servicio de Nefrologia
state: Navarra
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Nefrologia
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital de Basurto; Servicio de Nefrologia
state: Vizcaya
city: Galdakao
country: Spain
facility: Hospital de Galdakano; Servicio de Nefrologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Nefrologia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Nefrologia
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos; Servicio de Nefrologia
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus; Dept. of Nephrology
city: Eskilstuna
country: Sweden
facility: Maelar Hospital; Department of Medicine
city: Uppsala
country: Sweden
facility: Uppsala University Hospital; Department of Internal Medicine, Nephrology Section
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Fundation Kaohsiung Branch; Nephrology
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Nephrology Dept
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division
city: Phitsanulok
country: Thailand
facility: Buddhachinaraj Hospital Renal Division; Dept of Medicine
city: Adana
country: Turkey
facility: Cukurova University School of Medicine; Nefrology Department
city: Ankara
country: Turkey
facility: Baskent University Hospital; Transplantation
city: Malatya
country: Turkey
facility: Inonu Uni School of Medicine
city: Belfast
country: United Kingdom
facility: Ulster Hospital; Nephrology
city: Belfast
country: United Kingdom
facility: Belfast City Hospital; Nephrology Unit
city: Bradford
country: United Kingdom
facility: St Luke'S Hospital; Renal Unit
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales; Institute of Nephrology
city: Carshalton
country: United Kingdom
facility: St Helier Hospital; Renal Unit
city: Coventry
country: United Kingdom
facility: University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital; Renal Unit
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital; Dept of Nephrology
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary; Renal Medicine
city: Ipswich
country: United Kingdom
facility: The Ipswich Hospital Nhs Trust; The Renal Unit
city: Leeds
country: United Kingdom
facility: St James Uni Hospital; Renal Unit
city: Leicester
country: United Kingdom
facility: Leicester General Hospital; Dept of Nephrology
city: London
country: United Kingdom
facility: Royal Free & University College Medical School; Centre for Nephrology
city: Middlesborough
country: United Kingdom
facility: James Cook Hospital; Nephrology
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital; Nephrology
city: Oxford
country: United Kingdom
facility: The Churchill; Oxford Kidney Unit
city: Plymouth
country: United Kingdom
facility: Derriford Hospital; Department Of Renal Medicine
city: Preston
country: United Kingdom
facility: Royal Preston Hospital; Department of Renal Medicine
city: Salford
country: United Kingdom
facility: Salford Royal Foundation Trust; Department Of Nephrology
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
city: Swansea
country: United Kingdom
facility: Morriston Hospital; Renal Medicine
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital; Renal Unit
city: West Sussex
country: United Kingdom
facility: Worthing Hospital; Renal Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB. Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1701-1710. doi: 10.2215/CJN.01380219. Epub 2019 Aug 16.