Anemia, Kidney Failure, Chronic
Conditions
Brief summary
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.
Interventions
DRUGDynepo
Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject
Sponsors
Shire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who complete Dynepo study SPD490-301. 2. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.
Exclusion criteria
1. Withdrawal, before Week 24, from study SPD490-301. 2. Pregnant or lactating women. 3. Uncontrolled hypertension. 4. Thrombocytopenia (platelet count \<75,000/mm3). 5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding). 6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study. 7. Androgen therapy in the 30 days immediately prior to enrolment in this study. 8. Known Human Immunodeficiency Virus (HIV) infection. 9. History of hypersensitivity to Dynepo. 10. Known to have Ab against EPO.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) | Over the course of 2 Years |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years | Baseline and 2 years |
| Change From Baseline in Hematocrits at 2 Years | Baseline and 2 years |
Countries
Belgium
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| Dynepo (Epoetin Delta) Twice Weekly (BIW) Epoetin delta (Dynepo) dosed twice-a-week | 15 |
| Dynepo Once Weekly (QW) Epoetin delta dosed once-a-week | 86 |
| Dynepo Once Every 2 Weeks (Q2W) Epoetin delta dosed once every 2 weeks | 47 |
| Dynepo Once Every 4 Weeks (Q4W) Epoetin delta dosed once every 4 weeks | 4 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 2 | 0 |
| Overall Study | Death | 0 | 2 | 3 | 2 |
| Overall Study | Kidney transplant | 0 | 6 | 2 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Study terminated | 14 | 74 | 40 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Dynepo (Epoetin Delta) Twice Weekly (BIW) | Dynepo Once Weekly (QW) | Dynepo Once Every 2 Weeks (Q2W) | Dynepo Once Every 4 Weeks (Q4W) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 91 Participants | 8 Participants | 55 Participants | 25 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 7 Participants | 31 Participants | 22 Participants | 1 Participants |
| Age, Continuous | 64.9 years STANDARD_DEVIATION 13.8 | 63.4 years STANDARD_DEVIATION 12.93 | 64.8 years STANDARD_DEVIATION 13.7 | 65.2 years STANDARD_DEVIATION 14.03 | 66.3 years STANDARD_DEVIATION 21.39 |
| Region of Enrollment Austria | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Belgium | 12 Participants | 0 Participants | 6 Participants | 6 Participants | 0 Participants |
| Region of Enrollment France | 11 Participants | 1 Participants | 6 Participants | 3 Participants | 1 Participants |
| Region of Enrollment Germany | 31 Participants | 5 Participants | 19 Participants | 7 Participants | 0 Participants |
| Region of Enrollment Italy | 42 Participants | 1 Participants | 24 Participants | 17 Participants | 0 Participants |
| Region of Enrollment Latvia | 13 Participants | 3 Participants | 7 Participants | 3 Participants | 0 Participants |
| Region of Enrollment Spain | 19 Participants | 0 Participants | 8 Participants | 8 Participants | 3 Participants |
| Region of Enrollment United Kingdom | 23 Participants | 5 Participants | 15 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Female | 58 Participants | 7 Participants | 33 Participants | 16 Participants | 2 Participants |
| Sex: Female, Male Male | 94 Participants | 8 Participants | 53 Participants | 31 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 15 | 62 / 84 | 32 / 47 | 4 / 4 |
| serious Total, serious adverse events | 1 / 15 | 14 / 84 | 6 / 47 | 1 / 4 |
Outcome results
Primary
Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Over the course of 2 Years
Population: 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.
Secondary
Change From Baseline in Hematocrits at 2 Years
Time frame: Baseline and 2 years
Population: 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.
Secondary
Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years
Time frame: Baseline and 2 years
Population: 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.