Dynepo Infrequent Dosing Study

Phase 3

Terminated

Conditions: Anemia
Kidney Failure

Interventions: Drug: Dynepo (Epoetin delta)
Drug: Dynepo

Registration Number: NCT00450333

Lead Sponsor: Shire

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 407

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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.

Trial Locations

Locations (53): Hellig Hart Ziekenhuis, Campus Wilgenstraat
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Roeselare, Belgium
Hope Hospital
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Salford, Manchester, United Kingdom
Ospedale Nuovo Alessandro Manzoni
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Lecco, Lombardia, Italy
A.R.N.A.S Civico Palermo
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Palermo, Sicilia, Italy
Azienda Sanitaria Locale 4 Area Pratese
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Prato, Toscana, Italy
Hopital Sud, Service du Pr Fournier
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Salouel, France
Hopital Clemenceau, Nephrologie-Hemodialyse
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Caen Cedex 5, France
UZ Gasthuisberg, Leuve, Dept of Nephrology
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Leuven, Belgium
Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
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Innsbruck, Austria
CHU Hopital Civil, Nephrologie-Hemodialyse
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Strasbourg Cedex, France
Nephrologische Zentrum Villingen-Schwenningen
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Villingen-Schwenningen, Baden-Wurttemberg, Germany
Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
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Graz, Steiemark, Austria
CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
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Boulogne-sur-mer, France
Hopital UCL, Service de Nephrologie
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Bruxelles, Belgium
KfH Nierenzentrum Fulda
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Fulda, Hessen, Germany
CHU Hotel Dieu, Service du Pr Soulillou
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Nantes Cedex 1, France
CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
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Bordeaux Cedex, France
CHU (Centre Hospitalier Universitaire)
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Grenoble Cedex 9, France
Clinique de Landy, Service de Nephrologie - Hemodialyse
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Saint-Ouen, France
Hopital Rangueil, Service du Pr Durand
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Toulouse Cedex 4, France
Hopital Brabois Adultes, Nephrologie
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Vandoeuvre Les Nancy, France
KfH Nierenzebtrum im Linikum Rosenheim
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Rosenheim, Bavern, Germany
Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich
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Aachen, Nordrhein-Westfalen, Germany
Azienda Ospedaliera Universitaria Policlinico di Modena
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Modena, Emillia Romagna, Italy
Hospital Clinic i Provincial
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Barcelona, Spain
Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe
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Dusseldorf, Nordrhein-Westfalen, Germany
Hospital Universitario Reina Sofia
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Cordoba, Spain
Policlinico S. Orsola Malpighi
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Bologna, Emilia Romagna, Italy
Addenbrooke's Hospital
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Cambridge, United Kingdom
Hospital Puerto Real
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Puerto Real, Cadiz, Spain
Azienda Ospedaliera CTO/CRF/M.Adelaide
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Torino, Piemonte, Italy
Spedali Civil Brescia
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Brescia, Lombardia, Italy
Head of Nephrology, Fundacion Puigvert
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Barcelona, Spain
Ospedali Riuniti
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Foggia, Puglia, Italy
Hospital Vall d'Hebron
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Barcelona, Spain
Hotel General Universitario
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Castelló de la Plana, Castellon, Spain
Hospital Gregorio Maranon
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Madrid, Spain
Glasgow Western Infirmary
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Glasgow, United Kingdom
Hospital Doctor Peset
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Valencia, Spain
Hospital Central de Asturias
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Oviedo, Spain
Hospital Universitario Marques de Valdecilla
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Santander, Spain
Richard Bright Renal Unit Southmead Hospital
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Bristol, United Kingdom
New Cross Hospital
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Wolverhampton, United Kingdom
University Hospital of Wales
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Cardiff, United Kingdom
Morrison Hospital
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Swansea, United Kingdom
Kings College Hospital Renal Unit
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London, United Kingdom
KfK Nierenzentrum Nurnberg
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Nurnberg, Germany
KfH Nierenzentrum Bamberg
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Bamberg, Bayern, Germany
Praxis Dr. Vosskuhler
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Bottrop, Nordrhein Westfalen, Germany
Universita' degli Studi di Napoli Federico II
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Napoli, Campania, Italy
Dialyse-und Apheresezentrum Potsdam-Bebelsberg
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Potsdam, Brandenburg, Germany
Azienda Ospedaliera S.Giovanni-Addolorata
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Roma, Lazio, Italy
KfH Nierenzentrum am Handr-Klinikum Stralsund
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Stralsund, Mecklenburg-Vorpommern, Germany