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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:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00450333
First received: March 21, 2007
Last updated: June 6, 2014
Last verified: November 2009
Results First Received: August 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anemia
Kidney Failure
Interventions: Drug: Dynepo (Epoetin delta)
Drug: Dynepo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Erythropoietin (EPO)-naive subjects were randomized to receive Dynepo (Epoetin delta) once weekly (QW) or twice weekly (BIW) and subjects who were already stable on EPO (doses < or equal to 10,000 IU/week) were randomized to receive Dynepo once every 2 weeks (Q2W) or once weekly.

Reporting Groups
  Description
Dynepo (Epoetin Delta)-Naive Once-weekly (QW) Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
Dynepo-naive Twice-weekly (BIW) EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
Dynepo Once Every 2 Weeks (Q2W) EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
Dynepo QW EPO stable subjects receiving Epoetin delta once weekly (QW)

Participant Flow:   Overall Study
    Dynepo (Epoetin Delta)-Naive Once-weekly (QW)   Dynepo-naive Twice-weekly (BIW)   Dynepo Once Every 2 Weeks (Q2W)   Dynepo QW
STARTED   98   107   100   102 
COMPLETED   44   44   75   74 
NOT COMPLETED   54   63   25   28 
Study terminated                47                54                16                21 
Adverse Event                1                7                2                2 
Protocol Violation                1                0                1                0 
Withdrawal by Subject                1                0                3                0 
Kidney transplant                1                0                1                3 
Death                3                2                2                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dynepo (Epoetin Delta)-Naive Once-weekly (QW) Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
Dynepo-naive Twice-weekly (BIW) EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
Dynepo Once Every 2 Weeks (Q2W) EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
Dynepo QW EPO stable subjects receiving Epoetin delta once weekly (QW)
Total Total of all reporting groups

Baseline Measures
   Dynepo (Epoetin Delta)-Naive Once-weekly (QW)   Dynepo-naive Twice-weekly (BIW)   Dynepo Once Every 2 Weeks (Q2W)   Dynepo QW   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   107   100   102   407 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   37   35   48   35   155 
>=65 years   61   72   52   67   252 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.2  (14.97)   67.0  (12.45)   64.2  (13.86)   65.5  (16.04)   65.7  (14.33) 
Gender 
[Units: Participants]
         
Female   45   41   33   41   160 
Male   53   66   67   61   247 
Region of Enrollment 
[Units: Participants]
         
France   6   8   8   3   25 
Spain   3   2   13   14   32 
Belgium   2   2   12   11   27 
Austria   3   1   0   0   4 
Germany   15   16   15   14   60 
United Kingdom   10   15   11   12   48 
Italy   5   5   28   35   73 
Australia   19   22   7   6   54 
Hungary   8   8   0   1   17 
Latvia   14   16   4   4   38 
Lithuania   10   9   0   0   19 
New Zealand   3   3   2   2   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:   Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL   [ Time Frame: week 16 and 24 ]

3.  Secondary:   Change From Baseline in Hematocrits at 16 and 24 Weeks   [ Time Frame: Baseline and Weeks 16 and 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceuticals
e-mail: twhitaker@shire.com


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 )
Study First Received: March 21, 2007
Results First Received: August 18, 2009
Last Updated: June 6, 2014