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)
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.
2 other identifiers
interventional
2,825
26 countries
191
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2008
Longer than P75 for phase_4
191 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2008
CompletedFirst Posted
Study publicly available on registry
October 16, 2008
CompletedStudy Start
First participant enrolled
December 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2017
CompletedResults Posted
Study results publicly available
August 15, 2018
CompletedAugust 20, 2019
August 1, 2019
8.6 years
October 15, 2008
July 18, 2018
August 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Baseline up to approximately 8.5 years
Secondary Outcomes (7)
Time to All-Cause Mortality
Baseline up to approximately 8.5 years
Time to Non-Fatal and Fatal Myocardial Infarction
Baseline up to approximately 8.5 years
Time to Non-Fatal and Fatal Stroke
Baseline up to approximately 8.5 years
Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
Baseline up to approximately 8.5 years
Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
Baseline up to approximately 8.5 years
- +2 more secondary outcomes
Study Arms (2)
Erythropoiesis Stimulating Agents
ACTIVE COMPARATORParticipants will receive reference ESA according to approved label. The approved reference ESA compounds in the study will be darbepoetin alfa, epoetin alfa and epoetin beta.
Methoxy Polyethylene Glycol-Epoetin Beta
EXPERIMENTALParticipants not currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta iv or sc once every 2 weeks for correction of renal anemia (target Hb 10-12 g/dL). Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta will be administered once monthly.
Interventions
Darbepoetin alfa will be administered as per approved label.
Epoetin alfa will be administered as per approved label.
Epoetin beta will be administered as per approved label.
Participants who are currently not being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta administered at a starting dose of 0.6 mcg/kg body weight once every 2 weeks. Participants who are currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta at a dose of 120, 200 or 360 mcg once monthly (based on ESA dose administered in Week -1)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (196)
Fresenius Medical Care Martinez
Buenos Aires, 1640, Argentina
Fresenius Medical Care Morón
Buenos Aires, 1708, Argentina
Fresenius Medical Care San Martin
Buenos Aires, B1650IHM, Argentina
Fresenuis Medical Care Mansilla
CABA, 1425, Argentina
Gosford Hospital; Renal
Gosford, New South Wales, 2250, Australia
Renal Research Dr Simon Roger
Gosford, New South Wales, 2250, Australia
Cairns Hospital; Renal Services
Cairns, Queensland, 4870, Australia
Gold Coast Hospital Department of Pharmacology & Therapeutics
Southport, Queensland, 4215, Australia
ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS
Adelaide, South Australia, 5000, Australia
Launceston General Hospital; Diabetes and Renal Research Unit
Launceston, Tasmania, 7250, Australia
Monash Medical Centre; Renal Transplant Unit
Clayton, Victoria, 3186, Australia
Royal Perth Hospital; Nephrology
Perth, Western Australia, 6847, Australia
UZ Brussel
Brussels, 1090, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, 8800, Belgium
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, 36036-330, Brazil
PUCPR
Curitiba, Paraná, 80050-350, Brazil
Hospital Univ. Pedro Ernesto - Hupe; Nefrologia
Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, São Paulo, 01323-900, Brazil
Universidade Federal de Sao Paulo - UNIFESP
São Paulo, São Paulo, 04038-002, Brazil
Clinica de Medicina Interna e Nefrologia (CMIN)
São Paulo, São Paulo, 05001-000, Brazil
Hospital das Clinicas - FMUSP; Nefrologia
São Paulo, São Paulo, 05403-000, Brazil
Instituto de Hemodialise Sorocaba
Sorocaba, São Paulo, 18040-335, Brazil
General Hospital Karlovac; Dept of Haemodialysis
Karlovac, 47000, Croatia
Clinical Hospital Osijek; Dept of Haemodialysis
Osijek, 31000, Croatia
Clinical Hospital Center Rijeka; Dialysis
Rijeka, 51000, Croatia
General Hospital Josip Bencevic; Department of Haemodialysis
Slavonski Brod, 35000, Croatia
Clinical Hospital Split; Dialysis
Split, 21000, Croatia
General Hospital Zadar; Dialysis
Zadar, 23000, Croatia
Klinicki Bolnicki Centar Zagreb; Dialysis
Zagreb, 10000, Croatia
Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika
Hradec Králové, 500 05, Czechia
Faculty Hospital; Dialysis Unit
Ostrava, 708 52, Czechia
Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie
Prague, 140 21, Czechia
Nemocnice Strahov; Interni Oddeleni-Strahov
Prague, 169 00, Czechia
Centre Hospitalier; Hemodialyse
Annonay, 07103, France
Hopital Pellegrin; Departement Nephrologie
Bordeaux, 33076, France
Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse
Boulogne, 62321, France
Hopital La Cavale Blanche; Nephrologie
Brest, 29609, France
Hopital Louis Pasteur; Nephrologie - Hemodialyse
Colmar, 68024, France
Clinique Lambert; Service de Néphrologie dialyse
La Garenne-Colombes, 92250, France
Chu Dupuytren; Nephrologie-Hemodialyse
Limoges, 87042, France
Aural
Lyon, 69008, France
Hopital Edouard-Herriot; Nephrologie - Hemodialyse
Lyon, 69437, France
Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12
Mâcon, 71018, France
Service de Nephrologie & D'Immunologie; Clinique
Nantes, 44035, France
Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse
Nîmes, 30059, France
Aura - Centre Henri Kunt Ziger
Paris, 75014, France
Hopital Laennec; Echo
Saint-Herblain, 44805, France
Hopital Sud ; Nephrologie Hemodialyse
Salouël, 80480, France
Hopital Civil; Nephrologie Clinique Medicale B
Strasbourg, 67091, France
Hopital Rangueil; Nephrologie Hemodialyse
Toulouse, 31059, France
Ch De Valenciennes; Nephrologie
Valenciennes, 59322, France
Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst
Alsfeld, 36304, Germany
KFH Nierenzentrum Bad Hersfeld; Nephrologie
Bad Hersfeld, 36251, Germany
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
Bonn, 53127, Germany
Dialysepraxis Dr. med. Uwe Kraatz
Demmin, 17109, Germany
DaVita Clinical Research Deutschland GmbH
Düsseldorf, 40210, Germany
Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie
Düsseldorf, 40225, Germany
Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
Erlangen, 91054, Germany
Georg-Haas-Dialysezentrum der PHV
Giessen, 35392, Germany
Nephrologische Schwerpunktpraxis; Hamburg Barmbek
Hamburg, 22297, Germany
Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen
Hannoversch Münden, 34346, Germany
Uniklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
Homburg/Saar, 66424, Germany
UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV
Kiel, 24105, Germany
KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum
München, 80804, Germany
KFH Nierenzentrum Oberschleissheim
Oberschleißheim, 85764, Germany
Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.
Rostock, 18107, Germany
Praxis Dr.med. Joachim Leicht
Schwandorf in Bayern, 92421, Germany
Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie
Stuttgart, 70376, Germany
Uni Hospital of Alexandroupoli; Nephrology Dept.
Alexandroupoli, 68100, Greece
Laiko General Hospital; Nephrology Div.
Athens, 115 27, Greece
Uni Hospital of Ioannina; Nephrology Dept.
Ioannina, 455 00, Greece
Univeristy Hospital of Larissa; Nephrology
Larissa, 41 110, Greece
Hippokratio Hospital; Nefrology
Thessaloniki, 546 42, Greece
Rabin MC- Belinson campus
Petah Tikva, 49100, Israel
Rabin MC- Hasharon campus
Petah Tikva, 4937211, Israel
Sheba MC; Nephrology
Ramat Gan, 52621, Israel
Sourasky MC; Dept. of Nephrology
Tel Aviv, 6423906, Israel
Assaf-Harofeh MC; Nephrology
Zrifin, 70300, Israel
Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi
Carpi, Emilia-Romagna, 41012, Italy
Ospedale Civile; Servizio Di Nefrologia E Dialisi
Imola, Emilia-Romagna, 40026, Italy
A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi
Modena, Emilia-Romagna, 41100, Italy
Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi
Parma, Emilia-Romagna, 43100, Italy
Ospedale Civile; Divisione de Nefrologia E Dialisi
Piacenza, Emilia-Romagna, 29100, Italy
Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi
Ravenna, Emilia-Romagna, 48100, Italy
A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi
Reggio Emilia, Emilia-Romagna, 42100, Italy
Universita' Di Tor Vergata; Clinica Nefrologia Dialisi
Rome, Lazio, 00100, Italy
A.O. Universitaria S. Martino Di Genova; Nefrologia
Genoa, Liguria, 16132, Italy
Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi
Bollate, Lombardy, 20021, Italy
ASST DI LECCO; Nefrologia e Dialisi
Lecco, Lombardy, 23900, Italy
Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi
Milan, Lombardy, 20122, Italy
ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi
Milan, Lombardy, 20153, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
Milan, Lombardy, 20162, Italy
Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi
Pavia, Lombardy, 27100, Italy
ASST LARIANA; Divisione di Nefrologia e Dialisi
S Fermo Della Battaglia, Lombardy, 22020, Italy
Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi
Acireale, Sicily, 95024, Italy
Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia
Catania, Sicily, 95126, Italy
A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi
Messina, Sicily, 98147, Italy
Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi
Pesaro, The Marches, 61100, Italy
Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi
LODI, Tuscany, 26900, Italy
Nuovo Ospedale Di Prato
Prato, Tuscany, 50047, Italy
Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi
Castelfranco, Veneto, 31033, Italy
Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi
Cona (FE), Veneto, 44124, Italy
P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi
Conegliano, Veneto, 31015, Italy
Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi
Padua, Veneto, 35128, Italy
Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi
Rovigo, Veneto, 45100, Italy
A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti
Treviso, Veneto, 31100, Italy
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, 50009, Lithuania
Vilnius University Hospital Santariskiu Clinic, Nephrology Center
Vilnius, 08661, Lithuania
University Malaya Medical Centre; Division of Nephrology, Department of Medicine
Kuala Lumpur, FED. Territory of Kuala Lumpur, 50603, Malaysia
Hospital Kuala Lumpur; Department of Medicine
Kuala Lumpur, 50586, Malaysia
Selayang Hospital; Dept of Medicine
Kuala Selangor, 68100, Malaysia
Investigación Nefrológica S.C.
Cuernavaca, Morelos, 62448, Mexico
Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal
Panama City, 0834-02723, Panama
Cebu Doctors University Hospital
Cebu City, 6000, Philippines
National Kidney and Transplant Institute
Quezon City, 1100, Philippines
Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych
Bydgoszcz, 85-094, Poland
Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny
Ciechanów, 06-400, Poland
Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn
Dąbrowa Tarnowska, 33-200, Poland
NZOZ Stacja Dializ Hand-Prod w Gorlicach
Gorlice, 38-300, Poland
Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle
Jasło, 38-200, Poland
NZOZ Stacja Dializ Hand-Prod w Limanowej
Limanowa, 34-600, Poland
Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach
Pabianice, 95-200, Poland
Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu
Poznan, 61-485, Poland
Stacja Dializ NZOZ Centrum Medyczne MEDYK
Rzeszów, 35-055, Poland
Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu
Sandomierz, 27-600, Poland
Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice
Skierniewice, 96-100, Poland
Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii
Stalowa Wola, 37-450, Poland
Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny
Wałbrzych, 58-309, Poland
S.P. Szpital Wojewodzki im. Papieza Jana Pawla II
Zamość, 22-400, Poland
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
Saint Petersburg, Sankt-Peterburg, 197022, Russia
St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"
Saint Petersburg, 191104, Russia
SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF
Saint Petersburg, 195067, Russia
St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".
Saint Petersburg, 195257, Russia
Clinical Center of Serbia; Clinic of Urology
Belgrade, 11000, Serbia
Clinical Hospital Center Zvezdara
Belgrade, 11000, Serbia
Zemun Hospital; Nephrology
Belgrade, 11000, Serbia
Clinical Center Nis; Clinic for Nephrology and Hemodialysis
Niš, 18000, Serbia
Clinical Center Voivodina; Clinic for Immunology and Nephrology
Novi Sad, 21000, Serbia
National University Hospital; Dept of Medicine
Singapore, 117599, Singapore
Singapore General Hospital; Renal Medicine
Singapore, 169608, Singapore
Tan Tock Seng Hospital; Department of Renal Medicine
Singapore, 308433, Singapore
Seoul National Uni Hospital; Internal Medicine
Seoul, 03080, South Korea
Samsung Medical Center; Nephrology Department
Seoul, 06351, South Korea
Hospital Txagorritxu; Servicio de Nefrologia
Vitoria-Gasteiz, Alava, 01009, Spain
Complejo Hospitalario Torrecardenas; Servicio de Nefrologia
Almería, Almeria, 04009, Spain
Hospital Severo Ochoa; Servicio de Nefrologia
Leganés, Madrid, 28911, Spain
Hospital Infanta Sofia; Servico de Nefrologia
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital de Navarra; Servicio de Nefrologia
Pamplona, Navarre, 31008, Spain
Hospital de Cruces; Servicio de Nefrologia
Barakaldo, Vizcaya, 48903, Spain
Hospital de Basurto; Servicio de Nefrologia
Bilbao, Vizcaya, 48013, Spain
Hospital de Galdakano; Servicio de Nefrologia
Galdakao, Vizcaya, 48960, Spain
Hospital del Mar; Servicio de Nefrologia
Barcelona, 08003, Spain
Hospital Universitario San Cecilio
Granada, 18012, Spain
Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico
Jaén, 23007, Spain
Hospital Ramon y Cajal; Servicio de Nefrologia
Madrid, 28034, Spain
Hospital Clinico San Carlos; Servicio de Nefrologia
Madrid, 28040, Spain
Danderyds Sjukhus; Dept. of Nephrology
Danderyd, 18288, Sweden
Maelar Hospital; Department of Medicine
Eskilstuna, 63188, Sweden
Uppsala University Hospital; Department of Internal Medicine, Nephrology Section
Uppsala, 75185, Sweden
Chang Gung Medical Fundation Kaohsiung Branch; Nephrology
Kaohsiung City, 833, Taiwan
National Taiwan Uni Hospital; Nephrology Dept
Taipei, 100, Taiwan
King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine
Bangkok, 10310, Thailand
Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division
Chiang Mai, 50200, Thailand
Buddhachinaraj Hospital Renal Division; Dept of Medicine
Phitsanulok, 65000, Thailand
Cukurova University School of Medicine; Nefrology Department
Adana, 01100, Turkey (Türkiye)
Baskent University Hospital; Transplantation
Ankara, 06490, Turkey (Türkiye)
Inonu Uni School of Medicine
Malatya, 44300, Turkey (Türkiye)
Ulster Hospital; Nephrology
Belfast, BT16 1RH, United Kingdom
Belfast City Hospital; Nephrology Unit
Belfast, BT9 7LJ, United Kingdom
St Luke'S Hospital; Renal Unit
Bradford, BD5 0NA, United Kingdom
University Hospital of Wales; Institute of Nephrology
Cardiff, CF14 4XW, United Kingdom
St Helier Hospital; Renal Unit
Carshalton, SM5 1AA, United Kingdom
University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology
Coventry, CV2 2DX, United Kingdom
Dorset County Hospital; Renal Unit
Dorchester, DT1 1TS, United Kingdom
Royal Devon & Exeter Hospital; Dept of Nephrology
Exeter, EX2 5DW, United Kingdom
Hull Royal Infirmary; Renal Medicine
Hull, HU3 2JZ, United Kingdom
The Ipswich Hospital Nhs Trust; The Renal Unit
Ipswich, IP4 5PD, United Kingdom
St James Uni Hospital; Renal Unit
Leeds, LS9 7TF, United Kingdom
Leicester General Hospital; Dept of Nephrology
Leicester, LE5 4PW, United Kingdom
Royal Free & University College Medical School; Centre for Nephrology
London, NW3 2PF, United Kingdom
James Cook Hospital; Nephrology
Middlesbrough, TS4 3BW, United Kingdom
Freeman Hospital; Nephrology
Newcastle upon Tyne, NE7 7DN, United Kingdom
The Churchill; Oxford Kidney Unit
Oxford, OX3 7LJ, United Kingdom
Derriford Hospital; Department Of Renal Medicine
Plymouth, PL6 8DH, United Kingdom
Royal Preston Hospital; Department of Renal Medicine
Preston, PR2 9HT, United Kingdom
Salford Royal Foundation Trust; Department Of Nephrology
Salford, M6 8HD, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ, United Kingdom
Morriston Hospital; Renal Medicine
Swansea, SA6 6NL, United Kingdom
Royal Cornwall Hospital; Renal Unit
Truro, TR1 3LJ, United Kingdom
Worthing Hospital; Renal Unit
West Sussex, BN11 2DH, United Kingdom
Related Publications (2)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVEDLocatelli 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.
PMID: 31420350DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was designed and powered to formally test only the primary composite outcome measure only.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2008
First Posted
October 16, 2008
Study Start
December 12, 2008
Primary Completion
July 27, 2017
Study Completion
July 27, 2017
Last Updated
August 20, 2019
Results First Posted
August 15, 2018
Record last verified: 2019-08