A Study of Treatment With NeoRecormon (Epoetin Beta) in Patients With Chronic Renal Anemia
NCT ID: NCT00321919
Last Updated: 2016-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
605 participants
INTERVENTIONAL
2000-07-31
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early Epoetin Beta Therapy
Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
epoetin beta [NeoRecormon]
Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.
Late Epoetin Beta Therapy
Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to \<10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
epoetin beta [NeoRecormon]
Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to \<10.5 g/dL had occurred.
Interventions
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epoetin beta [NeoRecormon]
Participants in the early treatment group immediately started epoetin beta treatment to reach a target Hb level of 13-15 g/dL at the end of the correction phase.
epoetin beta [NeoRecormon]
Participants in the late treatment Group started epoetin beta treatment once a decline in Hb level to \<10.5 g/dL had occurred.
Eligibility Criteria
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Inclusion Criteria
* chronic renal anemia;
* not receiving renal replacement therapy.
Exclusion Criteria
* previous treatment with erythropoietin or other erythropoietic substance;
* blood transfusion within the last 3 months;
* need for dialysis expected in the next 6 months;
* administration of another investigational drug within 30 days preceding study start, or during the study.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Carnaxide, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Barcelona, , Spain
Las Palmas de Gran Canaria, , Spain
Madrid, , Spain
Madrid, , Spain
Linz, , Austria
Sankt Pölten, , Austria
Brussels, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Brno, , Czechia
Havířov, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Fredericia, , Denmark
Herlev, , Denmark
Holbæk, , Denmark
Roskilde, , Denmark
Jyväskylä, , Finland
Tampere, , Finland
Amiens, , France
Angoulême, , France
Bordeaux, , France
Boulogne, , France
Colmar, , France
Lyon, , France
Montpellier, , France
Paris, , France
Saint-Brieuc, , France
Troyes, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Villingen-Schwenningen, , Germany
Würzburg, , Germany
Athens, , Greece
Thessaloniki, , Greece
Véria, , Greece
Hong Kong, , Hong Kong
Dublin, , Ireland
Bologna, , Italy
Busto Arsizio, , Italy
Cagliari, , Italy
Cinisello Balsamo, , Italy
Lecco, , Italy
Napoli, , Italy
Padua, , Italy
Parma, , Italy
Pavia, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
San Giovanni Rotondo, , Italy
Trieste, , Italy
Vimercate, , Italy
Cuernavaca, , Mexico
Tijuana, , Mexico
Oslo, , Norway
Gdansk, , Poland
Kielce, , Poland
Krakow, , Poland
Wroclaw, , Poland
Almada, , Portugal
Valencia, , Spain
Borås, , Sweden
Helsingborg, , Sweden
Jönköping, , Sweden
Karlstad, , Sweden
Norrköping, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Belfast, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Salford, , United Kingdom
Southampton, , United Kingdom
Surrey, , United Kingdom
Countries
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References
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Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Locatelli F, Eckardt KU, Macdougall IC, Tsakiris D, Clyne N, Burger HU, Scherhag A, Drueke TB; Cardiovascular Risk Reduction in Early Anaemia Trial with Epoetin Beta investigators and coordinators. Value of N-terminal brain natriuretic peptide as a prognostic marker in patients with CKD: results from the CREATE study. Curr Med Res Opin. 2010 Nov;26(11):2543-52. doi: 10.1185/03007995.2010.516237. Epub 2010 Sep 17.
Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, Burger HU, Scherhag A; CREATE Investigators. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med. 2006 Nov 16;355(20):2071-84. doi: 10.1056/NEJMoa062276.
Other Identifiers
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BA16169
Identifier Type: -
Identifier Source: org_study_id
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