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DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)

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:
NCT00664066
First received: April 21, 2008
Last updated: September 28, 2009
Last verified: September 2009
History of Changes
Results First Received: August 18, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Anemia
Kidney Diseases
Renal Failure, Chronic
Kidney Failure, Chronic
Intervention: Drug: DYNEPO (epoetin delta)

  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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The decision to enrol a subject was not to be made until after the decision on erythropoietin therapy had been made by the physician and drug had been prescribed. Physicians were to manage subjects according to their local practices and protocols.

Reporting Groups
  Description
Dynepo Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits

Participant Flow:   Overall Study
    Dynepo  
STARTED     3  
COMPLETED     0  
NOT COMPLETED     3  
Study terminated                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Dynepo Epoetin delta dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits

Baseline Measures
    Dynepo  
Number of Participants  
[units: participants]
 		  3  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Age  
[units: years]
Mean ( Full Range ) 		  57.0  
  ( 57 to 57 )  
Gender  
[units: participants]
 		 
Female     1  
Male     2  
Region of Enrollment  
[units: participants]
 		 
Germany     3  



  Outcome Measures

1.  Primary:   Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo   [ Time Frame: up to 3 years ]
  Show Outcome Measure 1


  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 Pharmaceutical
e-mail: twhitaker@shire.com


No publications provided


Responsible Party: Timothy Whitaker M.D., Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00664066     History of Changes
Other Study ID Numbers: SPD490-404
Study First Received: April 21, 2008
Results First Received: August 18, 2009
Last Updated: September 28, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices