Dynepo Long-Term Safety Study

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
Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) at a dose that is appropriate for them and not to exceed 20,000 IU at any one time.

Reporting Groups

	Description
Dynepo (Epoetin Delta) Twice Weekly (BIW)	Epoetin delta (Dynepo) dosed twice-a-week
Dynepo Once Weekly (QW)	Epoetin delta dosed once-a-week
Dynepo Once Every 2 Weeks (Q2W)	Epoetin delta dosed once every 2 weeks
Dynepo Once Every 4 Weeks (Q4W)	Epoetin delta dosed once every 4 weeks

Participant Flow:   Overall Study

	Dynepo (Epoetin Delta) Twice Weekly (BIW)	Dynepo Once Weekly (QW)	Dynepo Once Every 2 Weeks (Q2W)	Dynepo Once Every 4 Weeks (Q4W)
STARTED	15	86	47	4
COMPLETED	0	0	0	0
NOT COMPLETED	15	86	47	4
Study terminated	14	74	40	2
Adverse Event	0	2	2	0
Protocol Violation	1	0	0	0
Withdrawal by Subject	0	1	0	0
Lack of Efficacy	0	1	0	0
Kidney transplant	0	6	2	0
Death	0	2	3	2

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) Twice Weekly (BIW)	Epoetin delta (Dynepo) dosed twice-a-week
Dynepo Once Weekly (QW)	Epoetin delta dosed once-a-week
Dynepo Once Every 2 Weeks (Q2W)	Epoetin delta dosed once every 2 weeks
Dynepo Once Every 4 Weeks (Q4W)	Epoetin delta dosed once every 4 weeks
Total	Total of all reporting groups

Baseline Measures

	Dynepo (Epoetin Delta) Twice Weekly (BIW)	Dynepo Once Weekly (QW)	Dynepo Once Every 2 Weeks (Q2W)	Dynepo Once Every 4 Weeks (Q4W)	Total
Overall Participants Analyzed  [Units: Participants]	15	86	47	4	152
Age  [Units: Participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	7	31	22	1	61
>=65 years	8	55	25	3	91
Age  [Units: Years] Mean (Standard Deviation)	63.4  (12.93)	64.8  (13.7)	65.2  (14.03)	66.3  (21.39)	64.9  (13.8)
Gender  [Units: Participants]
Female	7	33	16	2	58
Male	8	53	31	2	94
Region of Enrollment  [Units: Participants]
Belgium	0	6	6	0	12
Austria	0	1	0	0	1
France	1	6	3	1	11
Germany	5	19	7	0	31
Italy	1	24	17	0	42
Latvia	3	7	3	0	13
Spain	0	8	8	3	19
United Kingdom	5	15	3	0	23

1.  Primary:

Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Over the course of 2 Years ]

2.  Secondary:

Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years   [ Time Frame: Baseline and 2 years ]

3.  Secondary:

Change From Baseline in Hematocrits at 2 Years   [ Time Frame: Baseline and 2 years ]

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.