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)
August 16, 2019 updated by: Hoffmann-La Roche
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2825
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1640
- Fresenius Medical Care Martinez
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Buenos Aires, Argentina, 1708
- Fresenius Medical Care Morón
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Buenos Aires, Argentina, B1650IHM
- Fresenius Medical Care San Martin
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Caba, Argentina, 1425
- Fresenuis Medical Care Mansilla
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New South Wales
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Gosford, New South Wales, Australia, 2250
- Gosford Hospital; Renal
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Gosford, New South Wales, Australia, 2250
- Renal Research Dr Simon Roger
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Queensland
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Cairns, Queensland, Australia, 4870
- Cairns Hospital; Renal Services
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Southport, Queensland, Australia, 4215
- Gold Coast Hospital Department of Pharmacology & Therapeutics
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South Australia
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Adelaide, South Australia, Australia, 5000
- ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS
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Tasmania
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Launceston, Tasmania, Australia, 7250
- Launceston General Hospital; Diabetes and Renal Research Unit
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Victoria
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Clayton, Victoria, Australia, 3186
- Monash Medical Centre; Renal Transplant Unit
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Western Australia
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Perth, Western Australia, Australia, 6847
- Royal Perth Hospital; Nephrology
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Brussel, Belgium, 1090
- UZ Brussel
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Gent, Belgium, 9000
- UZ Gent
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Hasselt, Belgium, 3500
- Jessa Zkh (Campus Virga Jesse)
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Leuven, Belgium, 3000
- UZ Leuven Gasthuisberg
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Roeselare, Belgium, 8800
- AZ Delta (Campus Wilgenstraat)
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MG
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Juiz de Fora, MG, Brazil, 36036-330
- Centro Mineiro de Pesquisa - CMIP
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PR
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Curitiba, PR, Brazil, 80050-350
- PUCPR
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RJ
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Rio de Janeiro, RJ, Brazil, 20551-030
- Hospital Univ. Pedro Ernesto - Hupe; Nefrologia
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RS
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Porto Alegre, RS, Brazil, 90610-000
- Hospital Sao Lucas - PUCRS
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Porto Alegre, RS, Brazil, 90020-090
- Santa Casa de Misericordia de Porto Alegre
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SP
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Sao Paulo, SP, Brazil, 04038-002
- Universidade Federal de São Paulo - UNIFESP
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Sao Paulo, SP, Brazil, 01323-900
- Beneficencia Portuguesa de Sao Paulo
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Sao Paulo, SP, Brazil, 05001-000
- Clinica de Medicina Interna e Nefrologia (CMIN)
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Sao Paulo, SP, Brazil, 05403-000
- Hospital das Clinicas - FMUSP; Nefrologia
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Sorocaba, SP, Brazil, 18040-335
- Instituto de Hemodialise Sorocaba
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Karlovac, Croatia, 47000
- General Hospital Karlovac; Dept of Haemodialysis
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Osijek, Croatia, 31000
- Clinical Hospital Osijek; Dept of Haemodialysis
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Rijeka, Croatia, 51000
- Clinical Hospital Center Rijeka; Dialysis
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Slavonski Brod, Croatia, 35000
- General Hospital Josip Bencevic; Department of Haemodialysis
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Split, Croatia, 21000
- Clinical Hospital Split; Dialysis
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Zadar, Croatia, 23000
- General Hospital Zadar; Dialysis
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Zagreb, Croatia, 10000
- Klinicki Bolnicki Centar Zagreb; Dialysis
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Hradec Kralove, Czechia, 500 05
- Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika
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Ostrava, Czechia, 708 52
- Faculty Hospital; Dialysis Unit
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Praha, Czechia, 140 21
- Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie
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Praha 6, Czechia, 169 00
- Nemocnice Strahov; Interni Oddeleni-Strahov
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Annonay, France, 07103
- Centre Hospitalier; Hemodialyse
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Bordeaux, France, 33076
- Hopital Pellegrin; Departement Nephrologie
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Boulogne, France, 62321
- Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse
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Brest, France, 29609
- Hopital La Cavale Blanche; Nephrologie
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Colmar, France, 68024
- Hopital Louis Pasteur; Nephrologie - Hemodialyse
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La Garenne-Colombes, France, 92250
- Clinique Lambert; Service de Néphrologie dialyse
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Limoges, France, 87042
- Chu Dupuytren; Nephrologie-Hemodialyse
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Lyon, France, 69008
- Aural
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Lyon, France, 69437
- Hopital Edouard-Herriot; Nephrologie - Hemodialyse
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Macon, France, 71018
- Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12
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Nantes, France, 44035
- Service de Nephrologie & D'Immunologie; Clinique
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Nimes, France, 30059
- Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse
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Paris, France, 75014
- Aura - Centre Henri Kunt Ziger
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Saint Herblain, France, 44805
- Hopital Laennec; Echo
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Salouel, France, 80480
- Hopital Sud ; Nephrologie Hemodialyse
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Strasbourg, France, 67091
- Hopital Civil; Nephrologie Clinique Medicale B
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Toulouse, France, 31059
- Hopital Rangueil; Nephrologie Hemodialyse
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Valenciennes, France, 59322
- Ch De Valenciennes; Nephrologie
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Alsfeld, Germany, 36304
- Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst
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Bad Hersfeld, Germany, 36251
- KFH Nierenzentrum Bad Hersfeld; Nephrologie
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Bonn, Germany, 53127
- Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
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Demmin, Germany, 17109
- Dialysepraxis Dr. med. Uwe Kraatz
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Düsseldorf, Germany, 40210
- DaVita Clinical Research Deutschland GmbH
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Düsseldorf, Germany, 40225
- Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie
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Erlangen, Germany, 91054
- Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
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Gießen, Germany, 35392
- Georg-Haas-Dialysezentrum der PHV
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Hamburg, Germany, 22297
- Nephrologische Schwerpunktpraxis; Hamburg Barmbek
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Hann. Münden, Germany, 34346
- Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen
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Heidelberg, Germany, 69120
- Uniklinikum Heidelberg
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Homburg/Saar, Germany, 66424
- Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
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Kiel, Germany, 24105
- UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV
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München, Germany, 80804
- KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum
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Oberschleissheim, Germany, 85764
- KFH Nierenzentrum Oberschleissheim
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Rostock, Germany, 18107
- Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.
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Schwandorf, Germany, 92421
- Praxis Dr.med. Joachim Leicht
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Stuttgart, Germany, 70376
- Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie
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Alexandroupolis, Greece, 68100
- Uni Hospital of Alexandroupoli; Nephrology Dept.
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Athens, Greece, 115 27
- Laiko General Hospital; Nephrology Div.
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Ioannina, Greece, 455 00
- Uni Hospital of Ioannina; Nephrology Dept.
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Larissa, Greece, 41 110
- Univeristy Hospital of Larissa; Nephrology
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Thessaloniki, Greece, 546 42
- Hippokratio Hospital; Nefrology
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Petach Tikva, Israel, 49100
- Rabin MC- Belinson campus
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Petah Tikva, Israel, 4937211
- Rabin MC- Hasharon campus
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Ramat-Gan, Israel, 52621
- Sheba MC; Nephrology
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Tel Aviv, Israel, 6423906
- Sourasky MC; Dept. of Nephrology
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Zrifin, Israel, 70300
- Assaf-Harofeh MC; Nephrology
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Emilia-Romagna
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Carpi, Emilia-Romagna, Italy, 41012
- Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi
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Imola, Emilia-Romagna, Italy, 40026
- Ospedale Civile; Servizio Di Nefrologia E Dialisi
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Modena, Emilia-Romagna, Italy, 41100
- A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi
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Parma, Emilia-Romagna, Italy, 43100
- Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi
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Piacenza, Emilia-Romagna, Italy, 29100
- Ospedale Civile; Divisione de Nefrologia E Dialisi
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Ravenna, Emilia-Romagna, Italy, 48100
- Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi
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Reggio Emilia, Emilia-Romagna, Italy, 42100
- A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi
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Lazio
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Roma, Lazio, Italy, 00100
- Universita' Di Tor Vergata; Clinica Nefrologia Dialisi
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Liguria
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Genova, Liguria, Italy, 16132
- A.O. Universitaria S. Martino Di Genova; Nefrologia
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Lombardia
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Bollate, Lombardia, Italy, 20021
- Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi
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Lecco, Lombardia, Italy, 23900
- ASST DI LECCO; Nefrologia e Dialisi
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Milano, Lombardia, Italy, 20122
- Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi
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Milano, Lombardia, Italy, 20153
- ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi
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Milano, Lombardia, Italy, 20162
- ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
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Pavia, Lombardia, Italy, 27100
- Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi
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S Fermo Della Battaglia, Lombardia, Italy, 22020
- ASST LARIANA; Divisione di Nefrologia e Dialisi
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Marche
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Pesaro, Marche, Italy, 61100
- Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi
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Sicilia
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Acireale, Sicilia, Italy, 95024
- Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi
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Catania, Sicilia, Italy, 95126
- Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia
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Messina, Sicilia, Italy, 98147
- A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi
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Toscana
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Lodi, Toscana, Italy, 26900
- Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi
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Prato, Toscana, Italy, 50047
- Nuovo Ospedale di Prato
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Veneto
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Castelfranco, Veneto, Italy, 31033
- Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi
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Cona (FE), Veneto, Italy, 44124
- Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi
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Conegliano, Veneto, Italy, 31015
- P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi
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Padova, Veneto, Italy, 35128
- Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi
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Rovigo, Veneto, Italy, 45100
- Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi
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Treviso, Veneto, Italy, 31100
- A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti
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Seoul, Korea, Republic of, 03080
- Seoul National Uni Hospital; Internal Medicine
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center; Nephrology Department
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Kaunas, Lithuania, 50009
- Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
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Vilnius, Lithuania, 08661
- Vilnius University Hospital Santariskiu Clinic, Nephrology Center
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Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur; Department of Medicine
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Selangor, Malaysia, 68100
- Selayang Hospital; Dept of Medicine
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FED. Territory OF Kuala Lumpur
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Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia, 50603
- University Malaya Medical Centre; Division of Nephrology, Department of Medicine
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Morelos
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Cuernavaca, Morelos, Mexico, 62448
- Investigación Nefrológica S.C.
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Panama, Panama, 0834-02723
- Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal
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CEBU City, Philippines, 6000
- Cebu Doctors University Hospital
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Quezon City, Philippines, 1100
- National Kidney and Transplant Institute
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Bydgoszcz, Poland, 85-094
- Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych
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Ciechanow, Poland, 06-400
- Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny
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Dabrowa Tarnowska, Poland, 33-200
- Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn
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Gorlice, Poland, 38-300
- NZOZ Stacja Dializ Hand-Prod w Gorlicach
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Jaslo, Poland, 38-200
- Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle
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Limanowa, Poland, 34-600
- NZOZ Stacja Dializ Hand-Prod w Limanowej
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Pabianice, Poland, 95-200
- Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach
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Poznan, Poland, 61-485
- Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu
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Rzeszow, Poland, 35-055
- Stacja Dializ NZOZ Centrum Medyczne MEDYK
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Sandomierz, Poland, 27-600
- Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu
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Skierniewice, Poland, 96-100
- Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice
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Stalowa Wola, Poland, 37-450
- Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii
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Walbrzych, Poland, 58-309
- Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny
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Zamosc, Poland, 22-400
- S.P. Szpital Wojewodzki im. Papieza Jana Pawla II
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Saint-Petersburg, Russian Federation, 195067
- SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF
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St.Petersburg, Russian Federation, 191104
- St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"
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St.Petersburg, Russian Federation, 195257
- St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".
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Leningrad
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Sankt-peterburg, Leningrad, Russian Federation, 197022
- SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
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Belgrade, Serbia, 11000
- Clinical Hospital Center Zvezdara
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Belgrade, Serbia, 11000
- Clinical Center of Serbia; Clinic of Urology
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Belgrade, Serbia, 11000
- Zemun Hospital; Nephrology
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NIS, Serbia, 18000
- Clinical Center Nis; Clinic for Nephrology and Hemodialysis
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Novi Sad, Serbia, 21000
- Clinical Center Voivodina; Clinic for Immunology and Nephrology
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Singapore, Singapore, 117599
- National University Hospital; Dept of Medicine
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Singapore, Singapore, 169608
- Singapore General Hospital; Renal Medicine
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Singapore, Singapore, 308433
- Tan Tock Seng Hospital; Department of Renal Medicine
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Barcelona, Spain, 08003
- Hospital del Mar; Servicio de Nefrologia
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Granada, Spain, 18012
- Hospital Universitario San Cecilio
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Jaen, Spain, 23007
- Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico
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Madrid, Spain, 28040
- Hospital Clinico San Carlos; Servicio de Nefrologia
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Madrid, Spain, 28034
- Hospital Ramon y Cajal; Servicio de Nefrologia
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Alava
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Vitoria, Alava, Spain, 01009
- Hospital Txagorritxu; Servicio de Nefrologia
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Almeria
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Almería, Almeria, Spain, 04009
- Complejo Hospitalario Torrecardenas; Servicio de Nefrologia
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Madrid
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Leganes, Madrid, Spain, 28911
- Hospital Severo Ochoa; Servicio de Nefrologia
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San Sebastian de los Reyes, Madrid, Spain, 28702
- Hospital Infanta Sofia; Servico de Nefrologia
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Navarra
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Pamplona, Navarra, Spain, 31008
- Hospital de Navarra; Servicio de Nefrologia
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Vizcaya
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Barakaldo, Vizcaya, Spain, 48903
- Hospital de Cruces; Servicio de Nefrologia
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Bilbao, Vizcaya, Spain, 48013
- Hospital de Basurto; Servicio de Nefrologia
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Galdakao, Vizcaya, Spain, 48960
- Hospital de Galdakano; Servicio de Nefrologia
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Danderyd, Sweden, 18288
- Danderyds Sjukhus; Dept. of Nephrology
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Eskilstuna, Sweden, 63188
- Maelar Hospital; Department of Medicine
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Uppsala, Sweden, 75185
- Uppsala University Hospital; Department of Internal Medicine, Nephrology Section
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Kaohsiung, Taiwan, 833
- Chang Gung Medical Fundation Kaohsiung Branch; Nephrology
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Taipei, Taiwan, 100
- National Taiwan Uni Hospital; Nephrology Dept
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Bangkok, Thailand, 10310
- King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine
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Chiang Mai, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division
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Phitsanulok, Thailand, 65000
- Buddhachinaraj Hospital Renal Division; Dept of Medicine
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Adana, Turkey, 01100
- Cukurova University School of Medicine; Nefrology Department
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Ankara, Turkey, 06490
- Baskent University Hospital; Transplantation
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Malatya, Turkey, 44300
- Inonu Uni School of Medicine
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Belfast, United Kingdom, BT16 1RH
- Ulster Hospital; Nephrology
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Belfast, United Kingdom, BT9 7LJ
- Belfast City Hospital; Nephrology Unit
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Bradford, United Kingdom, BD5 0NA
- St Luke'S Hospital; Renal Unit
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Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales; Institute of Nephrology
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Carshalton, United Kingdom, SM5 1AA
- St Helier Hospital; Renal Unit
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Coventry, United Kingdom, CV2 2DX
- University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology
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Dorchester, United Kingdom, DT1 1TS
- Dorset County Hospital; Renal Unit
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Exeter, United Kingdom, EX2 5DW
- Royal Devon & Exeter Hospital; Dept of Nephrology
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Hull, United Kingdom, HU3 2JZ
- Hull Royal Infirmary; Renal Medicine
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Ipswich, United Kingdom, IP4 5PD
- The Ipswich Hospital Nhs Trust; The Renal Unit
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Leeds, United Kingdom, LS9 7TF
- St James Uni Hospital; Renal Unit
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Leicester, United Kingdom, LE5 4PW
- Leicester General Hospital; Dept of Nephrology
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London, United Kingdom, NW3 2PF
- Royal Free & University College Medical School; Centre for Nephrology
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Middlesborough, United Kingdom, TS4 3BW
- James Cook Hospital; Nephrology
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
- Freeman Hospital; Nephrology
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Oxford, United Kingdom, OX3 7LJ
- The Churchill; Oxford Kidney Unit
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Plymouth, United Kingdom, PL6 8DH
- Derriford Hospital; Department Of Renal Medicine
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Preston, United Kingdom, PR2 9HT
- Royal Preston Hospital; Department of Renal Medicine
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Salford, United Kingdom, M6 8HD
- Salford Royal Foundation Trust; Department Of Nephrology
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Shrewsbury, United Kingdom, SY3 8XQ
- Royal Shrewsbury Hospital
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Swansea, United Kingdom, SA6 6NL
- Morriston Hospital; Renal Medicine
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Truro, United Kingdom, TR1 3LJ
- Royal Cornwall Hospital; Renal Unit
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West Sussex, United Kingdom, BN11 2DH
- Worthing Hospital; Renal Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Erythropoiesis Stimulating Agents
Participants 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.
|
Darbepoetin alfa will be administered as per approved label.
Other Names:
Epoetin alfa will be administered as per approved label.
Other Names:
Epoetin beta will be administered as per approved label.
Other Names:
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)
Other Names:
|
|
Experimental: Methoxy Polyethylene Glycol-Epoetin Beta
Participants 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.
|
Darbepoetin alfa will be administered as per approved label.
Other Names:
Epoetin alfa will be administered as per approved label.
Other Names:
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)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to All-Cause Mortality
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
|
Time to Non-Fatal and Fatal Myocardial Infarction
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
|
Time to Non-Fatal and Fatal Stroke
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
|
Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
|
Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
|
Percentage of Participants With Gastrointestinal Bleeding
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
|
Percentage of Participants With Thromboembolic Events
Time Frame: Baseline up to approximately 8.5 years
|
Baseline up to approximately 8.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2008
Primary Completion (Actual)
July 27, 2017
Study Completion (Actual)
July 27, 2017
Study Registration Dates
First Submitted
October 15, 2008
First Submitted That Met QC Criteria
October 15, 2008
First Posted (Estimate)
October 16, 2008
Study Record Updates
Last Update Posted (Actual)
August 20, 2019
Last Update Submitted That Met QC Criteria
August 16, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BH21260
- 2007-005129-31
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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