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)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00773513 |
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Recruitment Status :
Completed
First Posted : October 16, 2008
Results First Posted : August 15, 2018
Last Update Posted : September 19, 2018
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Renal Anemia | Drug: Darbepoetin Alfa Drug: Epoetin Alfa Drug: Epoetin Beta Drug: methoxy polyethylene glycol-epoetin beta | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2825 participants |
| 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. |
| Actual Study Start Date : | December 12, 2008 |
| Actual Primary Completion Date : | July 27, 2017 |
| Actual Study Completion Date : | July 27, 2017 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Progressive external ophthalmoplegia
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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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.
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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® |
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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® |
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, Whichever Occurred First [ Time Frame: Baseline up to approximately 8.5 years ]
Secondary Outcome Measures :
- Time to All-Cause Mortality [ Time Frame: Baseline up to approximately 8.5 years ]
- Time to Non-Fatal and Fatal Myocardial Infarction [ Time Frame: Baseline up to approximately 8.5 years ]
- Time to Non-Fatal and Fatal Stroke [ Time Frame: 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 ]
- Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA) [ Time Frame: Baseline up to approximately 8.5 years ]
- Percentage of Participants With Gastrointestinal Bleeding [ Time Frame: Baseline up to approximately 8.5 years ]
- Percentage of Participants With Thromboembolic Events [ Time Frame: Baseline up to approximately 8.5 years ]
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 City, 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 HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF | |
| Sankt-peterburg, Leningrad, Russian Federation, 197022 | |
| SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF | |
| Saint-Petersburg, Russian Federation, 195067 | |
| 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 |
Study Documents (Full-Text)
Documents provided by Hoffmann-La Roche:
Documents provided by Hoffmann-La Roche:
Study Protocol and Statistical Analysis Plan [PDF] March 23, 2015
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00773513 History of Changes |
| Other Study ID Numbers: |
BH21260 2007-005129-31 |
| First Posted: | October 16, 2008 Key Record Dates |
| Results First Posted: | August 15, 2018 |
| Last Update Posted: | September 19, 2018 |
| Last Verified: | August 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
Epoetin Alfa Darbepoetin alfa Hematinics |