Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
407 participants
INTERVENTIONAL
2006-10-30
2008-07-31
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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1
Erythropoietin(EPO)-naive BIW
Dynepo (Epoetin delta)
subcutaneous, BIW for 24 weeks
2
EPO-naive QW
Dynepo
subcutaneous, QW for 24 weeks
3
EPO QW
Dynepo
subcutaneous, QW for 24 weeks
4
EPO Q2W
Dynepo
subcutaneous, Q2W for 24 weeks
Interventions
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Dynepo (Epoetin delta)
subcutaneous, BIW for 24 weeks
Dynepo
subcutaneous, QW for 24 weeks
Dynepo
subcutaneous, QW for 24 weeks
Dynepo
subcutaneous, Q2W for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Stable on and taking doses \<= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.
* Transferrin saturation \>= 20% and ferritin \>= 100 ng/mL.
Exclusion Criteria
* Requiring doses of EPO \> 10,000 IU/week.
* Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.
* Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).
* Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.
* Androgen therapy in the 30 days immediately prior to randomisation in the study.
* Known Human Immunodeficiency Virus(HIV)infection.
* History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
Graz, Steiemark, Austria
Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
Innsbruck, , Austria
Hopital UCL, Service de Nephrologie
Brussels, , Belgium
UZ Gasthuisberg, Leuve, Dept of Nephrology
Leuven, , Belgium
Hellig Hart Ziekenhuis, Campus Wilgenstraat
Roeselare, , Belgium
CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
Bordeaux, , France
CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
Boulogne-sur-Mer, , France
Hopital Clemenceau, Nephrologie-Hemodialyse
Caen, , France
CHU (Centre Hospitalier Universitaire)
Grenoble, , France
CHU Hotel Dieu, Service du Pr Soulillou
Nantes, , France
Clinique de Landy, Service de Nephrologie - Hemodialyse
Saint-Ouen, , France
Hopital Sud, Service du Pr Fournier
Salouël, , France
CHU Hopital Civil, Nephrologie-Hemodialyse
Strasbourg, , France
Hopital Rangueil, Service du Pr Durand
Toulouse, , France
Hopital Brabois Adultes, Nephrologie
Vandœuvre-lès-Nancy, , France
Nephrologische Zentrum Villingen-Schwenningen
Villingen-Schwenningen, Baden-Wurttemberg, Germany
KfH Nierenzentrum Bamberg
Bamberg, Bavaria, Germany
KfH Nierenzebtrum im Linikum Rosenheim
Rosenheim, Bavern, Germany
Dialyse-und Apheresezentrum Potsdam-Bebelsberg
Potsdam, Brandenburg, Germany
KfH Nierenzentrum Fulda
Fulda, Hesse, Germany
KfH Nierenzentrum am Handr-Klinikum Stralsund
Stralsund, Mecklenburg-Vorpommern, Germany
Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich
Aachen, North Rhine-Westphalia, Germany
Praxis Dr. Vosskuhler
Bottrop, North Rhine-Westphalia, Germany
Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe
Düsseldorf, North Rhine-Westphalia, Germany
KfK Nierenzentrum Nurnberg
Nuremberg, , Germany
Ospedali Riuniti
Foggia, Apulia, Italy
Universita' degli Studi di Napoli Federico II
Napoli, Campania, Italy
Policlinico S. Orsola Malpighi
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Policlinico di Modena
Modena, Emillia Romagna, Italy
Azienda Ospedaliera S.Giovanni-Addolorata
Rome, Lazio, Italy
Spedali Civil Brescia
Brescia, Lombardy, Italy
Ospedale Nuovo Alessandro Manzoni
Lecco, Lombardy, Italy
Azienda Ospedaliera CTO/CRF/M.Adelaide
Turin, Piedmont, Italy
A.R.N.A.S Civico Palermo
Palermo, Sicily, Italy
Azienda Sanitaria Locale 4 Area Pratese
Prato, Tuscany, Italy
Hospital Puerto Real
Puerto Real, Cadiz, Spain
Hotel General Universitario
Castellon, Castellon, Spain
Head of Nephrology, Fundacion Puigvert
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Gregorio Maranon
Madrid, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Doctor Peset
Valencia, , Spain
Hope Hospital
Salford, Manchester, United Kingdom
Richard Bright Renal Unit Southmead Hospital
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
Glasgow Western Infirmary
Glasgow, , United Kingdom
Kings College Hospital Renal Unit
London, , United Kingdom
Morrison Hospital
Swansea, , United Kingdom
New Cross Hospital
Wolverhampton, , 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.
Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.
Other Identifiers
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2006-002052-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD490-301
Identifier Type: -
Identifier Source: org_study_id
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