Dynepo Infrequent Dosing Study
This study has been terminated.
(The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA)
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00450333
First received: March 21, 2007
Last updated: November 25, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia Kidney Failure |
Drug: Dynepo (Epoetin delta) Drug: Dynepo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL [ Time Frame: week 16 and 24 ] [ Designated as safety issue: Yes ]
- Change From Baseline in Hematocrits at 16 and 24 Weeks [ Time Frame: Baseline and Weeks 16 and 24 ] [ Designated as safety issue: Yes ]
| Enrollment: | 407 |
| Study Start Date: | October 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Erythropoietin(EPO)-naive BIW
|
Drug: Dynepo (Epoetin delta)
subcutaneous, BIW for 24 weeks
|
|
Active Comparator: 2
EPO-naive QW
|
Drug: Dynepo
subcutaneous, QW for 24 weeks
|
|
Active Comparator: 3
EPO QW
|
Drug: Dynepo
subcutaneous, QW for 24 weeks
|
|
Active Comparator: 4
EPO Q2W
|
Drug: Dynepo
subcutaneous, Q2W for 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450333
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| Austria | |
| Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse | |
| Graz, Steiemark, Austria, A-8036 | |
| Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie | |
| Innsbruck, Austria, A-6020 | |
| Belgium | |
| Hopital UCL, Service de Nephrologie | |
| Bruxelles, Belgium, B-1200 | |
| UZ Gasthuisberg, Leuve, Dept of Nephrology | |
| Leuven, Belgium, B-3000 | |
| Hellig Hart Ziekenhuis, Campus Wilgenstraat | |
| Roeselare, Belgium, B-8800 | |
| France | |
| CHU - Hopital Pellegrin, Nephrologie-Hemodialyse | |
| Bordeaux Cedex, France, 33076 | |
| CH de Boulogne-sur-mer (Hopital de Dr Duchenne) | |
| Boulogne-sur-mer, France, 62321 | |
| Hopital Clemenceau, Nephrologie-Hemodialyse | |
| Caen Cedex 5, France, 14033 | |
| CHU (Centre Hospitalier Universitaire) | |
| Grenoble Cedex 9, France, 38043 | |
| CHU Hotel Dieu, Service du Pr Soulillou | |
| Nantes Cedex 1, France, 44093 | |
| Clinique de Landy, Service de Nephrologie - Hemodialyse | |
| Saint-Ouen, France, 93400 | |
| Hopital Sud, Service du Pr Fournier | |
| Salouel, France, 80480 | |
| CHU Hopital Civil, Nephrologie-Hemodialyse | |
| Strasbourg Cedex, France, 67091 | |
| Hopital Rangueil, Service du Pr Durand | |
| Toulouse Cedex 4, France, 31403 | |
| Hopital Brabois Adultes, Nephrologie | |
| Vandoeuvre Les Nancy, France, 54511 | |
| Germany | |
| Nephrologische Zentrum Villingen-Schwenningen | |
| Villingen-Schwenningen, Baden-Wurttemberg, Germany, 78054 | |
| KfH Nierenzebtrum im Linikum Rosenheim | |
| Rosenheim, Bavern, Germany, 83022 | |
| KfH Nierenzentrum Bamberg | |
| Bamberg, Bayern, Germany, 96050 | |
| Dialyse-und Apheresezentrum Potsdam-Bebelsberg | |
| Potsdam-Babelsberg, Brandenburg, Germany, 14482 | |
| KfH Nierenzentrum Fulda | |
| Fulda, Hessen, Germany, 36043 | |
| KfH Nierenzentrum am Handr-Klinikum Stralsund | |
| Stralsund, Mecklenburg-Vorpommern, Germany, 18435 | |
| Praxis Dr. Vosskuhler | |
| Bottrop, Nordrhein Westfalen, Germany, 46242 | |
| Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich | |
| Aachen, Nordrhein-Westfalen, Germany, 52074 | |
| Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe | |
| Dusseldorf, Nordrhein-Westfalen, Germany, 40210 | |
| KfK Nierenzentrum Nurnberg | |
| Nurnberg, Germany, 90471 | |
| Italy | |
| Universita' degli Studi di Napoli Federico II | |
| Napoli, Campania, Italy, 80131 | |
| Policlinico S. Orsola Malpighi | |
| Bologna, Emilia Romagna, Italy, 40138 | |
| Azienda Ospedaliera Universitaria Policlinico di Modena | |
| Modena, Emillia Romagna, Italy, 41100 | |
| Azienda Ospedaliera S.Giovanni-Addolorata | |
| Roma, Lazio, Italy, 00184 | |
| Spedali Civil Brescia | |
| Brescia, Lombardia, Italy, 25123 | |
| Ospedale Nuovo Alessandro Manzoni | |
| Lecco, Lombardia, Italy, 23900 | |
| Azienda Ospedaliera CTO/CRF/M.Adelaide | |
| Torino, Piemonte, Italy, 10126 | |
| Ospedali Riuniti | |
| Foggia, Puglia, Italy, 71100 | |
| A.R.N.A.S Civico Palermo | |
| Palermo, Sicilia, Italy, 90127 | |
| Azienda Sanitaria Locale 4 Area Pratese | |
| Prato, Toscana, Italy, 59100 | |
| Spain | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Head of Nephrology, Fundacion Puigvert | |
| Barcelona, Spain, 08025 | |
| Hospital Clinic i Provincial | |
| Barcelona, Spain, 08036 | |
| Hotel General Universitario | |
| Castellon, Spain, 120004 | |
| Hospital Universitario Reina Sofia | |
| Cordoba, Spain, 14004 | |
| Hospital Gregorio Maranon | |
| Madrid, Spain, 28007 | |
| Hospital Central de Asturias | |
| Oviedo, Spain, 33006 | |
| Hospital Puerto Real | |
| Puerto Real, Cadiz, Spain, 11510 | |
| Hospital Universitario Marques de Valdecilla | |
| Santander, Spain, 39008 | |
| Hospital Doctor Peset | |
| Valencia, Spain, 46017 | |
| United Kingdom | |
| Hope Hospital | |
| Salford, Manchester, United Kingdom, M6 8HD | |
| Richard Bright Renal Unit Southmead Hospital | |
| Bristol, United Kingdom, BS10 5NB | |
| Addenbrooke's Hospital | |
| Cambridge, United Kingdom, CB2 0QQ | |
| University Hospital of Wales | |
| Cardiff, United Kingdom, CF14 4XW | |
| Glasgow Western Infirmary | |
| Glasgow, United Kingdom, G11 6NT | |
| Kings College Hospital Renal Unit | |
| London, United Kingdom, SE5 9RS | |
| Morrison Hospital | |
| Swansea, United Kingdom, SA6 6NL | |
| New Cross Hospital | |
| Wolverhampton, United Kingdom, WV10 0QP | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | Iain C Macdougall, MD | Kings College Hospital, London |
More Information
No publications provided
| Responsible Party: | Timothy Whitaker, M.D., Shire |
| ClinicalTrials.gov Identifier: | NCT00450333 History of Changes |
| Other Study ID Numbers: | SPD490-301 |
| Study First Received: | March 21, 2007 |
| Results First Received: | August 18, 2009 |
| Last Updated: | November 25, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Shire Development LLC:
|
Chronic |
Additional relevant MeSH terms:
|
Anemia Renal Insufficiency Renal Insufficiency, Chronic Hematologic Diseases Kidney Diseases Urologic Diseases |
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013