Dynepo Infrequent Dosing Study

Phase 3

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).
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

Uncontrolled hypertension.
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.

Arm && Interventions

Group	Intervention	Description
1	Dynepo (Epoetin delta)	Erythropoietin(EPO)-naive BIW
2	Dynepo	EPO-naive QW
3	Dynepo	EPO QW
4	Dynepo	EPO Q2W

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks	Baseline 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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL	week 16 and 24	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.
Change From Baseline in Hematocrits at 16 and 24 Weeks	Baseline and Weeks 16 and 24	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.

Locations (53): Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
🇦🇹
Graz, Steiemark, Austria
Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
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Innsbruck, Austria
Hopital UCL, Service de Nephrologie
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Bruxelles, Belgium
UZ Gasthuisberg, Leuve, Dept of Nephrology
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Leuven, Belgium
Hellig Hart Ziekenhuis, Campus Wilgenstraat
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Roeselare, Belgium
CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
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Bordeaux Cedex, France
CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
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Boulogne-sur-mer, France
Hopital Clemenceau, Nephrologie-Hemodialyse
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Caen Cedex 5, France
CHU (Centre Hospitalier Universitaire)
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Grenoble Cedex 9, France
CHU Hotel Dieu, Service du Pr Soulillou
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Nantes Cedex 1, France
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Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
🇦🇹Graz, Steiemark, Austria