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

History of Changes

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.
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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
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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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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 Pharmaceuticals
e-mail: twhitaker@shire.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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