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

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:

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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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.
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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
Overall Participants Analyzed [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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

Results Point of Contact:

Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceutical
e-mail: twhitaker@shire.com

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

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