Dynepo Infrequent Dosing Study

Anemia Clinical Trial

Official title:

An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis

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
• 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
• 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.

Related Conditions & MeSH terms

• Anemia
• Kidney Failure
• Renal Insufficiency

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