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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00450333
Other study ID # SPD490-301
Secondary ID 2006-002052-15
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 30, 2006
Est. completion date July 31, 2008

Study information

Verified date June 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility

Status Terminated
Enrollment 407
Est. completion date July 31, 2008
Est. primary completion date July 31, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Shire

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 24 weeks
Secondary 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. week 16 and 24
Secondary 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. Baseline and Weeks 16 and 24
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