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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 Development LLC
ClinicalTrials.gov Identifier:
NCT00450333
First received: March 21, 2007
Last updated: November 25, 2009
Last verified: November 2009
History of Changes
Results First Received: August 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   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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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  
Number of Participants  
[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
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1.  Primary:   Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks   [ Time Frame: Baseline and 24 weeks ]
  Show Outcome Measure 1

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

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


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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.  


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


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