Clinical trial NCT00450333: Dynepo Infrequent Dosing Study
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Kidney Failure
Keywords: Chronic
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-03-22
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
timeFrame: week 16 and 24
measure: Change From Baseline in Hematocrits at 16 and 24 Weeks
timeFrame: Baseline and Weeks 16 and 24
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
state: Steiemark
city: Innsbruck
country: Austria
facility: Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
city: Bruxelles
country: Belgium
facility: Hopital UCL, Service de Nephrologie
city: Leuven
country: Belgium
facility: UZ Gasthuisberg, Leuve, Dept of Nephrology
city: Roeselare
country: Belgium
facility: Hellig Hart Ziekenhuis, Campus Wilgenstraat
city: Bordeaux Cedex
country: France
facility: CHU - Hopital Pellegrin, Nephrologie-Hemodialyse
city: Boulogne-sur-mer
country: France
facility: CH de Boulogne-sur-mer (Hopital de Dr Duchenne)
city: Caen Cedex 5
country: France
facility: Hopital Clemenceau, Nephrologie-Hemodialyse
city: Grenoble Cedex 9
country: France
facility: CHU (Centre Hospitalier Universitaire)
city: Nantes Cedex 1
country: France
facility: CHU Hotel Dieu, Service du Pr Soulillou
city: Saint-Ouen
country: France
facility: Clinique de Landy, Service de Nephrologie - Hemodialyse
city: Salouel
country: France
facility: Hopital Sud, Service du Pr Fournier
city: Strasbourg Cedex
country: France
facility: CHU Hopital Civil, Nephrologie-Hemodialyse
city: Toulouse Cedex 4
country: France
facility: Hopital Rangueil, Service du Pr Durand
city: Vandoeuvre Les Nancy
country: France
facility: Hopital Brabois Adultes, Nephrologie
city: Villingen-Schwenningen
country: Germany
facility: Nephrologische Zentrum Villingen-Schwenningen
state: Baden-Wurttemberg
city: Rosenheim
country: Germany
facility: KfH Nierenzebtrum im Linikum Rosenheim
state: Bavern
city: Bamberg
country: Germany
facility: KfH Nierenzentrum Bamberg
state: Bayern
city: Potsdam
country: Germany
facility: Dialyse-und Apheresezentrum Potsdam-Bebelsberg
state: Brandenburg
city: Fulda
country: Germany
facility: KfH Nierenzentrum Fulda
state: Hessen
city: Stralsund
country: Germany
facility: KfH Nierenzentrum am Handr-Klinikum Stralsund
state: Mecklenburg-Vorpommern
city: Bottrop
country: Germany
facility: Praxis Dr. Vosskuhler
state: Nordrhein Westfalen
city: Aachen
country: Germany
facility: Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich
state: Nordrhein-Westfalen
city: Dusseldorf
country: Germany
facility: Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe
state: Nordrhein-Westfalen
city: Nurnberg
country: Germany
facility: KfK Nierenzentrum Nurnberg
city: Napoli
country: Italy
facility: Universita' degli Studi di Napoli Federico II
state: Campania
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
state: Emilia Romagna
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico di Modena
state: Emillia Romagna
city: Roma
country: Italy
facility: Azienda Ospedaliera S.Giovanni-Addolorata
state: Lazio
city: Brescia
country: Italy
facility: Spedali Civil Brescia
state: Lombardia
city: Lecco
country: Italy
facility: Ospedale Nuovo Alessandro Manzoni
state: Lombardia
city: Torino
country: Italy
facility: Azienda Ospedaliera CTO/CRF/M.Adelaide
state: Piemonte
city: Foggia
country: Italy
facility: Ospedali Riuniti
state: Puglia
city: Palermo
country: Italy
facility: A.R.N.A.S Civico Palermo
state: Sicilia
city: Prato
country: Italy
facility: Azienda Sanitaria Locale 4 Area Pratese
state: Toscana
city: Puerto Real
country: Spain
facility: Hospital Puerto Real
state: Cadiz
city: Castelló de la Plana
country: Spain
facility: Hotel General Universitario
state: Castellon
city: Barcelona
country: Spain
facility: Head of Nephrology, Fundacion Puigvert
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Salford
country: United Kingdom
facility: Hope Hospital
state: Manchester
city: Bristol
country: United Kingdom
facility: Richard Bright Renal Unit Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Glasgow
country: United Kingdom
facility: Glasgow Western Infirmary
city: London
country: United Kingdom
facility: Kings College Hospital Renal Unit
city: Swansea
country: United Kingdom
facility: Morrison Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35.