The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
407
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Time frame: Baseline and 24 weeks
Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Time frame: week 16 and 24
Change From Baseline in Hematocrits at 16 and 24 Weeks
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Time frame: Baseline and Weeks 16 and 24
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subcutaneous, Q2W for 24 weeks
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
...and 43 more locations