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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00773513
First received: October 15, 2008
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Chronic Renal Anemia Drug: Darbepoetin Alfa Drug: Epoetin Alfa Drug: Epoetin Beta Drug: methoxy polyethylene glycol-epoetin beta Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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, Whatever Occurs First [ Time Frame: Event driven (Baseline up to approximately 10 years) ]

Secondary Outcome Measures:
  • Time to Death [ Time Frame: Event driven (Baseline up to approximately 10 years) ]
  • Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurs First) [ Time Frame: Event driven (Baseline up to approximately 10 years) ]
  • Time to Non-Fatal Myocardial Infarction [ Time Frame: Event driven (Baseline up to approximately 10 years) ]
  • Time to Non-Fatal Stroke [ Time Frame: Event driven (Baseline up to approximately 10 years) ]
  • Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA) [ Time Frame: Baseline up to approximately 10 years ]
  • Percentage of Participants With Gastrointestinal Bleeding [ Time Frame: Event driven (Baseline up to approximately 10 years) ]
  • Percentage of Participants With Thromboembolic Events [ Time Frame: Event driven (Baseline up to approximately 10 years) ]

Enrollment: 2828
Actual Study Start Date: December 31, 2008
Estimated Study Completion Date: July 31, 2017
Estimated Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Darbepoetin Alfa
Darbepoetin alfa will be administered as per approved label.
Other Name: Aranesp®, Nespo®, Aranest®
Drug: Epoetin Alfa
Epoetin alfa will be administered as per approved label.
Other Name: Eprex®, Epogen®, Epopen®, Erypo®
Drug: Epoetin Beta
Epoetin beta will be administered as per approved label.
Other Name: Neorecormon®, Recormon®
Drug: methoxy polyethylene glycol-epoetin beta
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 Name: Mircera®
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.
Drug: Darbepoetin Alfa
Darbepoetin alfa will be administered as per approved label.
Other Name: Aranesp®, Nespo®, Aranest®
Drug: Epoetin Alfa
Epoetin alfa will be administered as per approved label.
Other Name: Eprex®, Epogen®, Epopen®, Erypo®
Drug: methoxy polyethylene glycol-epoetin beta
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 Name: Mircera®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773513

  Hide Study Locations
Locations
Argentina
Fresenius Medical Care Martinez
Buenos Aires, Argentina, 1640
Fresenius Medical Care Morón
Buenos Aires, Argentina, 1708
Fresenius Medical Care San Martin
Buenos Aires, Argentina, B1650IHM
Fresenuis Medical Care Mansilla
Caba, Argentina, 1425
Australia, New South Wales
Gosford Hospital; Renal
Gosford, New South Wales, Australia, 2250
Renal Research Dr Simon Roger
Gosford, New South Wales, Australia, 2250
Australia, Queensland
Cairns Hospital; Renal Services
Cairns, Queensland, Australia, 4870
Gold Coast Hospital Department of Pharmacology & Therapeutics
Southport, Queensland, Australia, 4215
Australia, South Australia
ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Launceston General Hospital; Diabetes and Renal Research Unit
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Monash Medical Centre; Renal Transplant Unit
Clayton, Victoria, Australia, 3186
Australia, Western Australia
Royal Perth Hospital; Nephrology
Perth, Western Australia, Australia, 6847
Belgium
UZ Brussel
Brussel, Belgium, 1090
UZ Gent
Gent, Belgium, 9000
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium, 3500
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
AZ Delta (Campus Wilgenstraat)
Roeselare, Belgium, 8800
Brazil
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, MG, Brazil, 36036-330
PUCPR
Curitiba, PR, Brazil, 80050-350
Hospital Univ. Pedro Ernesto - Hupe; Nefrologia
Rio de Janeiro, RJ, Brazil, 20551-030
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90020-090
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Beneficencia Portuguesa de Sao Paulo
Sao Paulo, SP, Brazil, 01323-900
Universidade Federal de Sao Paulo - UNIFESP
Sao Paulo, SP, Brazil, 04038-002
Clinica de Medicina Interna e Nefrologia (CMIN)
Sao Paulo, SP, Brazil, 05001-000
Hospital das Clinicas - FMUSP; Nefrologia
Sao Paulo, SP, Brazil, 05403-000
Instituto de Hemodialise Sorocaba
Sorocaba, SP, Brazil, 18040-335
Croatia
General Hospital Karlovac; Dept of Haemodialysis
Karlovac, Croatia, 47000
Clinical Hospital Osijek; Dept of Haemodialysis
Osijek, Croatia, 31000
Clinical Hospital Center Rijeka; Dialysis
Rijeka, Croatia, 51000
General Hospital Josip Bencevic; Department of Haemodialysis
Slavonski Brod, Croatia, 35000
Clinical Hospital Split; Dialysis
Split, Croatia, 21000
General Hospital Zadar; Dialysis
Zadar, Croatia, 23000
Klinicki Bolnicki Centar Zagreb; Dialysis
Zagreb, Croatia, 10000
Czechia
Fakultni Nemocnice Hradec Kralove; Nephrology
Hradec Kralove, Czechia, 500 05
Faculty Hospital; Dialysis Unit
Ostrava, Czechia, 708 52
Nemocnice Strahov; Interni Oddeleni-Strahov
Praha 6, Czechia, 169 00
Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie
Praha, Czechia, 140 21
France
Centre Hospitalier; Hemodialyse
Annonay, France, 07103
Hopital Pellegrin; Departement Nephrologie
Bordeaux, France, 33076
Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse
Boulogne, France, 62321
Hopital La Cavale Blanche; Nephrologie
Brest, France, 29609
Hopital Louis Pasteur; Nephrologie - Hemodialyse
Colmar, France, 68024
Clinique Lambert; Service de Néphrologie dialyse
La Garenne-Colombes, France, 92250
Chu Dupuytren; Nephrologie-Hemodialyse
Limoges, France, 87042
Aural
Lyon, France, 69008
Hopital Edouard-Herriot; Nephrologie - Hemodialyse
Lyon, France, 69437
Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12
Macon, France, 71018
Service de Nephrologie & D'Immunologie; Clinique
Nantes, France, 44035
Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse
Nimes, France, 30059
Aura - Centre Henri Kunt Ziger
Paris, France, 75014
Hopital Laennec; Echo
Saint Herblain, France, 44805
Hopital Sud ; Nephrologie Hemodialyse
Salouel, France, 80480
Hopital Civil; Nephrologie Clinique Medicale B
Strasbourg, France, 67091
Hopital Rangueil; Nephrologie Hemodialyse
Toulouse, France, 31059
Ch De Valenciennes; Nephrologie
Valenciennes, France, 59322
Germany
Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst
Alsfeld, Germany, 36304
KFH Nierenzentrum Bad Hersfeld; Nephrologie
Bad Hersfeld, Germany, 36251
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
Bonn, Germany, 53127
Dialysepraxis Dr. med. Uwe Kraatz
Demmin, Germany, 17109
DaVita Clinical Research Deutschland GmbH
Düsseldorf, Germany, 40210
Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie
Düsseldorf, Germany, 40225
Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie
Erlangen, Germany, 91054
Georg-Haas-Dialysezentrum der PHV
Gießen, Germany, 35392
Nephrologische Schwerpunktpraxis; Hamburg Barmbek
Hamburg, Germany, 22297
Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen
Hann. Münden, Germany, 34346
Uniklinikum Heidelberg
Heidelberg, Germany, 69120
Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV
Homburg/Saar, Germany, 66424
UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV
Kiel, Germany, 24105
Kfh Dialysezentrum
München, Germany, 80804
KFH Nierenzentrum Oberschleissheim
Oberschleissheim, Germany, 85764
Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.
Rostock, Germany, 18107
Praxis Dr.med. Joachim Leicht
Schwandorf, Germany, 92421
Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie
Stuttgart, Germany, 70376
Greece
Uni Hospital of Alexandroupoli; Nephrology Dept.
Alexandroupolis, Greece, 68100
Laiko General Hospital; Nephrology Div.
Athens, Greece, 115 27
Uni Hospital of Ioannina; Nephrology Dept.
Ioannina, Greece, 455 00
Univeristy Hospital of Larissa; Nephrology
Larissa, Greece, 41 110
Hippokratio Hospital; Nefrology
Thessaloniki, Greece, 546 42
Israel
Rabin MC- Belinson campus
Petach Tikva, Israel, 49100
Rabin MC- Hasharon campus
Petah Tikva, Israel, 4937211
Sheba MC; Nephrology
Ramat-Gan, Israel, 52621
Sourasky MC; Dept. of Nephrology
Tel Aviv, Israel, 6423906
Assaf-Harofeh MC; Nephrology
Zrifin, Israel, 70300
Italy
Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi
Carpi, Emilia-Romagna, Italy, 41012
Ospedale Civile; Servizio Di Nefrologia E Dialisi
Imola, Emilia-Romagna, Italy, 40026
A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi
Modena, Emilia-Romagna, Italy, 41100
Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi
Parma, Emilia-Romagna, Italy, 43100
Ospedale Civile; Divisione de Nefrologia E Dialisi
Piacenza, Emilia-Romagna, Italy, 29100
Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi
Ravenna, Emilia-Romagna, Italy, 48100
A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi
Reggio Emilia, Emilia-Romagna, Italy, 42100
Universita' Di Tor Vergata; Clinica Nefrologia Dialisi
Roma, Lazio, Italy, 00100
A.O. Universitaria S. Martino Di Genova; Nefrologia
Genova, Liguria, Italy, 16132
Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi
Bollate, Lombardia, Italy, 20021
ASST DI LECCO; Nefrologia e Dialisi
Lecco, Lombardia, Italy, 23900
Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi
Milano, Lombardia, Italy, 20122
ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi
Milano, Lombardia, Italy, 20153
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi
Milano, Lombardia, Italy, 20162
Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi
Pavia, Lombardia, Italy, 27100
ASST LARIANA; Divisione di Nefrologia e Dialisi
S Fermo Della Battaglia, Lombardia, Italy, 22020
Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi
Pesaro, Marche, Italy, 61100
Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi
Acireale, Sicilia, Italy, 95024
Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia
Catania, Sicilia, Italy, 95126
A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi
Messina, Sicilia, Italy, 98147
Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi
Lodi, Toscana, Italy, 26900
Nuovo Ospedale Di Prato
Prato, Toscana, Italy, 50047
Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi
Castelfranco, Veneto, Italy, 31033
Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi
Cona (FE), Veneto, Italy, 44124
P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi
Conegliano, Veneto, Italy, 31015
Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi
Padova, Veneto, Italy, 35128
Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi
Rovigo, Veneto, Italy, 45100
A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti
Treviso, Veneto, Italy, 31100
Korea, Republic of
Seoul National Uni Hospital; Internal Medicine
Seoul, Korea, Republic of, 03080
Samsung Medical Center; Nephrology Department
Seoul, Korea, Republic of, 06351
Lithuania
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics
Kaunas, Lithuania, 50009
Vilnius University Hospital Santariskiu Clinic, Nephrology Center
Vilnius, Lithuania, 08661
Malaysia
University Malaya Medical Centre; Division of Nephrology, Department of Medicine
Kuala Lumpur, Fed. Territory of Kuala Lumpur, Malaysia, 50603
Hospital Kuala Lumpur; Department of Medicine
Kuala Lumpur, Malaysia, 50586
Selayang Hospital; Dept of Medicine
Selangor, Malaysia, 68100
Mexico
Investigación Nefrológica S.C.
Cuernavaca, Morelos, Mexico, 62448
Panama
Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal
Panama, Panama, 0834-02723
Philippines
Cebu Doctors University Hospital
CEBU City, Philippines, 6000
National Kidney and Transplant Institute
Quezon, Philippines, 1100
Poland
Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych
Bydgoszcz, Poland, 85-094
Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny
Ciechanow, Poland, 06-400
Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn
Dabrowa Tarnowska, Poland, 33-200
NZOZ Stacja Dializ Hand-Prod w Gorlicach
Gorlice, Poland, 38-300
Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle
Jaslo, Poland, 38-200
NZOZ Stacja Dializ Hand-Prod w Limanowej
Limanowa, Poland, 34-600
Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach
Pabianice, Poland, 95-200
Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu
Poznan, Poland, 61-485
Stacja Dializ NZOZ Centrum Medyczne MEDYK
Rzeszow, Poland, 35-055
Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu
Sandomierz, Poland, 27-600
Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice
Skierniewice, Poland, 96-100
Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii
Stalowa Wola, Poland, 37-450
Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny
Walbrzych, Poland, 58-309
S.P. Szpital Wojewodzki im. Papieza Jana Pawla II
Zamosc, Poland, 22-400
Russian Federation
SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF
Saint-Petersburg, Russian Federation, 195067
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
St Petersburg, Russian Federation, 197089
St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"
St.Petersburg, Russian Federation, 191104
St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".
St.Petersburg, Russian Federation, 195257
Serbia
Clinical Center of Serbia; Clinic of Urology
Belgrade, Serbia, 11000
Clinical Hospital Center Zvezdara
Belgrade, Serbia, 11000
Zemun Hospital; Nephrology
Belgrade, Serbia, 11000
Clinical Center Nis; Clinic for Nephrology and Hemodialysis
NIS, Serbia, 18000
Clinical Center Voivodina; Clinic for Immunology and Nephrology
Novi Sad, Serbia, 21000
Singapore
National University Hospital; Dept of Medicine
Singapore, Singapore, 117599
Singapore General Hospital; Renal Medicine
Singapore, Singapore, 169608
Tan Tock Seng Hospital; Department of Renal Medicine
Singapore, Singapore, 308433
Spain
Hospital Txagorritxu; Servicio de Nefrologia
Vitoria, Alava, Spain, 01009
Complejo Hospitalario Torrecardenas; Servicio de Nefrologia
Almería, Almeria, Spain, 04009
Hospital Severo Ochoa; Servicio de Nefrologia
Leganes, Madrid, Spain, 28911
Hospital Infanta Sofia; Servico de Nefrologia
San Sebastian de los Reyes, Madrid, Spain, 28702
Hospital de Navarra; Servicio de Nefrologia
Pamplona, Navarra, Spain, 31008
Hospital de Cruces; Servicio de Nefrologia
Barakaldo, Vizcaya, Spain, 48903
Hospital de Basurto; Servicio de Nefrologia
Bilbao, Vizcaya, Spain, 48013
Hospital de Galdakano; Servicio de Nefrologia
Galdakao, Vizcaya, Spain, 48960
Hospital del Mar; Servicio de Nefrologia
Barcelona, Spain, 08003
Hospital Universitario San Cecilio
Granada, Spain, 18012
Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico
Jaen, Spain, 23007
Hospital Ramon y Cajal; Servicio de Nefrologia
Madrid, Spain, 28034
Hospital Clinico San Carlos; Servicio de Nefrologia
Madrid, Spain, 28040
Sweden
Danderyds Sjukhus; Dept. of Nephrology
Danderyd, Sweden, 18288
Maelar Hospital; Department of Medicine
Eskilstuna, Sweden, 63188
Uppsala University Hospital; Department of Internal Medicine, Nephrology Section
Uppsala, Sweden, 75185
Taiwan
Chang Gung Medical Fundation Kaohsiung Branch; Nephrology
Kaohsiung, Taiwan, 833
National Taiwan Uni Hospital; Nephrology Dept
Taipei, Taiwan, 100
Thailand
King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine
Bangkok, Thailand, 10310
Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division
Chiang Mai, Thailand, 50200
Buddhachinaraj Hospital Renal Division; Dept of Medicine
Phitsanulok, Thailand, 65000
Turkey
Cukurova University School of Medicine; Nefrology Department
Adana, Turkey, 01100
Baskent University Hospital; Transplantation
Ankara, Turkey, 06490
Inonu Uni School of Medicine
Malatya, Turkey, 44300
United Kingdom
Ulster Hospital; Nephrology
Belfast, United Kingdom, BT16 1RH
Belfast City Hospital; Nephrology Unit
Belfast, United Kingdom, BT9 7LJ
St Luke'S Hospital; Renal Unit
Bradford, United Kingdom, BD5 0NA
University Hospital of Wales; Institute of Nephrology
Cardiff, United Kingdom, CF14 4XW
St Helier Hospital; Renal Unit
Carshalton, United Kingdom, SM5 1AA
University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology
Coventry, United Kingdom, CV2 2DX
Dorset County Hospital; Renal Unit
Dorchester, United Kingdom, DT1 1TS
Royal Devon & Exeter Hospital; Dept of Nephrology
Exeter, United Kingdom, EX2 5DW
Hull Royal Infirmary; Renal Medicine
Hull, United Kingdom, HU3 2JZ
The Ipswich Hospital Nhs Trust; The Renal Unit
Ipswich, United Kingdom, IP4 5PD
St James Uni Hospital; Renal Unit
Leeds, United Kingdom, LS9 7TF
Leicester General Hospital; Dept of Nephrology
Leicester, United Kingdom, LE5 4PW
Royal Free & University College Medical School; Centre for Nephrology
London, United Kingdom, NW3 2PF
James Cook Hospital; Nephrology
Middlesborough, United Kingdom, TS4 3BW
Freeman Hospital; Nephrology
Newcastle Upon Tyne, United Kingdom, NE7 7DN
The Churchill; Oxford Kidney Unit
Oxford, United Kingdom, OX3 7LJ
Derriford Hospital; Department Of Renal Medicine
Plymouth, United Kingdom, PL6 8DH
Royal Preston Hospital; Department of Renal Medicine
Preston, United Kingdom, PR2 9HT
Salford Royal Foundation Trust; Department Of Nephrology
Salford, United Kingdom, M6 8HD
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom, SY3 8XQ
Morriston Hospital; Renal Medicine
Swansea, United Kingdom, SA6 6NL
Royal Cornwall Hospital; Renal Unit
Truro, United Kingdom, TR1 3LJ
Worthing Hospital; Renal Unit
West Sussex, United Kingdom, BN11 2DH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773513     History of Changes
Other Study ID Numbers: BH21260
2007-005129-31
Study First Received: October 15, 2008
Last Updated: June 19, 2017

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Darbepoetin alfa
Hematinics

ClinicalTrials.gov processed this record on August 21, 2017