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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:
ClinicalTrials.gov Identifier:
NCT00450333
First Posted: March 22, 2007
Last Update Posted: June 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shire
March 21, 2007
March 22, 2007
August 18, 2009
November 10, 2009
June 12, 2014
October 2006
July 2008   (Final data collection date for primary outcome measure)
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.
Primary endpoint is mean Haemoglobin (Hb) concentration calculated at Week 12.
Complete list of historical versions of study NCT00450333 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Number (%) of patients who achieve Hb of >= 11g/dL at Week 12.
  • Number (%) of patients who achieve the Haematocrit (Hct) target range of 33%-36% at Week 12.
  • Number (%) of patients who achieve both Hb of >=11g/dL and the Hct target range of 33%-36% at Week 12.
  • Patients' average weekly dose/kg over Weeks 9-12.
  • Mean Hb concentration calculated over Weeks 13-24.
  • Mean Hct calculated at Week 12 and over Weeks 13 to 24.
  • Patients' average weekly dose/kg over Weeks 13 to 24.
  • Number (%) of patients with a positive antibody response to Dynepo.
  • Number (%) of patients shown to have neutralising antibodies.
  • Blood pressure changes from Baseline.
  • Changes in Left Ventricular Ejection Fraction from the Screening visit.
  • Renal function using the estimated Glomerular Filtration Rate.
  • Retinopathy in diabetic patients.
Not Provided
Not Provided
 
Dynepo Infrequent Dosing Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Anemia
  • Kidney Failure
  • Drug: Dynepo (Epoetin delta)
    subcutaneous, BIW for 24 weeks
  • Drug: Dynepo
    subcutaneous, QW for 24 weeks
  • Drug: Dynepo
    subcutaneous, Q2W for 24 weeks
  • Active Comparator: 1
    Erythropoietin(EPO)-naive BIW
    Intervention: Drug: Dynepo (Epoetin delta)
  • Active Comparator: 2
    EPO-naive QW
    Intervention: Drug: Dynepo
  • Active Comparator: 3
    EPO QW
    Intervention: Drug: Dynepo
  • Active Comparator: 4
    EPO Q2W
    Intervention: Drug: Dynepo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
407
July 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Italy,   Spain,   United Kingdom
 
 
NCT00450333
SPD490-301
2006-002052-15 ( EudraCT Number )
No
Not Provided
Not Provided
Timothy Whitaker, M.D., Shire
Shire
Not Provided
Principal Investigator: Iain C Macdougall, MD Kings College Hospital, London
Shire
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP