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Clinical Trial Details

Trial ID: L0794
Source ID: NCT00773513
Associated Drug: Darbepoetin Alfa
Title: 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)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00773513/results
Conditions: Chronic Renal Anemia
Interventions: DRUG: Darbepoetin Alfa|DRUG: Epoetin Alfa|DRUG: Epoetin Beta|DRUG: methoxy polyethylene glycol-epoetin beta
Outcome Measures: Primary: 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: 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|Percentage of Participants With Gastrointestinal Bleeding, Baseline up to approximately 8.5 years|Percentage of Participants With Thromboembolic Events, Baseline up to approximately 8.5 years
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 2825
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-12-12
Completion Date: 2017-07-27
Results First Posted: 2018-08-15
Last Update Posted: 2019-08-20
Locations: 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, Brussel, 1090, Belgium|UZ Gent, Gent, 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, MG, 36036-330, Brazil|PUCPR, Curitiba, PR, 80050-350, Brazil|Hospital Univ. Pedro Ernesto - Hupe; Nefrologia, Rio de Janeiro, RJ, 20551-030, Brazil|Santa Casa de Misericordia de Porto Alegre, Porto Alegre, RS, 90020-090, Brazil|Hospital Sao Lucas - PUCRS, Porto Alegre, RS, 90610-000, Brazil|Beneficencia Portuguesa de Sao Paulo, Sao Paulo, SP, 01323-900, Brazil|Universidade Federal de Sao Paulo - UNIFESP, Sao Paulo, SP, 04038-002, Brazil|Clinica de Medicina Interna e Nefrologia (CMIN), Sao Paulo, SP, 05001-000, Brazil|Hospital das Clinicas - FMUSP; Nefrologia, Sao Paulo, SP, 05403-000, Brazil|Instituto de Hemodialise Sorocaba, Sorocaba, SP, 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 Kralove, 500 05, Czechia|Faculty Hospital; Dialysis Unit, Ostrava, 708 52, Czechia|Nemocnice Strahov; Interni Oddeleni-Strahov, Praha 6, 169 00, Czechia|Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie, Praha, 140 21, 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, Macon, 71018, France|Service de Nephrologie & D'Immunologie; Clinique, Nantes, 44035, France|Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse, Nimes, 30059, France|Aura - Centre Henri Kunt Ziger, Paris, 75014, France|Hopital Laennec; Echo, Saint Herblain, 44805, France|Hopital Sud ; Nephrologie Hemodialyse, Salouel, 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, Hann. 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, 92421, Germany|Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie, Stuttgart, 70376, Germany|Uni Hospital of Alexandroupoli; Nephrology Dept., Alexandroupolis, 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, Petach 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, Roma, Lazio, 00100, Italy|A.O. Universitaria S. Martino Di Genova; Nefrologia, Genova, Liguria, 16132, Italy|Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi, Bollate, Lombardia, 20021, Italy|ASST DI LECCO; Nefrologia e Dialisi, Lecco, Lombardia, 23900, Italy|Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi, Milano, Lombardia, 20122, Italy|ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi, Milano, Lombardia, 20153, Italy|ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi, Milano, Lombardia, 20162, Italy|Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi, Pavia, Lombardia, 27100, Italy|ASST LARIANA; Divisione di Nefrologia e Dialisi, S Fermo Della Battaglia, Lombardia, 22020, Italy|Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi, Pesaro, Marche, 61100, Italy|Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi, Acireale, Sicilia, 95024, Italy|Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia, Catania, Sicilia, 95126, Italy|A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi, Messina, Sicilia, 98147, Italy|Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi, Lodi, Toscana, 26900, Italy|Nuovo Ospedale Di Prato, Prato, Toscana, 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, Padova, 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|Seoul National Uni Hospital; Internal Medicine, Seoul, 03080, Korea, Republic of|Samsung Medical Center; Nephrology Department, Seoul, 06351, Korea, Republic of|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, Selangor, 68100, Malaysia|Investigación Nefrológica S.C., Cuernavaca, Morelos, 62448, Mexico|Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal, Panama, 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, Ciechanow, 06-400, Poland|Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn, Dabrowa 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, Jaslo, 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, Rzeszow, 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, Walbrzych, 58-309, Poland|S.P. Szpital Wojewodzki im. Papieza Jana Pawla II, Zamosc, 22-400, Poland|SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF, Sankt-peterburg, Leningrad, 197022, Russian Federation|SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF, Saint-Petersburg, 195067, Russian Federation|St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital", St.Petersburg, 191104, Russian Federation|St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth"., St.Petersburg, 195257, Russian Federation|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, NIS, 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|Hospital Txagorritxu; Servicio de Nefrologia, Vitoria, Alava, 01009, Spain|Complejo Hospitalario Torrecardenas; Servicio de Nefrologia, Almería, Almeria, 04009, Spain|Hospital Severo Ochoa; Servicio de Nefrologia, Leganes, Madrid, 28911, Spain|Hospital Infanta Sofia; Servico de Nefrologia, San Sebastian de los Reyes, Madrid, 28702, Spain|Hospital de Navarra; Servicio de Nefrologia, Pamplona, Navarra, 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, Jaen, 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, 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|Baskent University Hospital; Transplantation, Ankara, 06490, Turkey|Inonu Uni School of Medicine, Malatya, 44300, Turkey|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, Middlesborough, 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
URL: https://clinicaltrials.gov/show/NCT00773513