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Dynepo Infrequent Dosing Study

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ClinicalTrials.gov Identifier: NCT00450333
Recruitment Status : 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)
First Posted : March 22, 2007
Results First Posted : November 10, 2009
Last Update Posted : June 12, 2014
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Anemia Kidney Failure Drug: Dynepo (Epoetin delta) Drug: Dynepo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks [ Time Frame: 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 :
  1. Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL [ Time Frame: 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.

  2. Change From Baseline in Hematocrits at 16 and 24 Weeks [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450333


  Show 53 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Iain C Macdougall, MD Kings College Hospital, London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy Whitaker, M.D., Shire
ClinicalTrials.gov Identifier: NCT00450333     History of Changes
Other Study ID Numbers: SPD490-301
2006-002052-15 ( EudraCT Number )
First Posted: March 22, 2007    Key Record Dates
Results First Posted: November 10, 2009
Last Update Posted: June 12, 2014
Last Verified: November 2009

Keywords provided by Shire:
Chronic

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics