Anemia, Kidney Failure
Conditions
Keywords
Chronic
Brief summary
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.
Interventions
subcutaneous, BIW for 24 weeks
DRUGDynepo
subcutaneous, QW for 24 weeks
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative \[KDOQI\] stage III-V). * Stable on and taking doses \<= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO. * Transferrin saturation \>= 20% and ferritin \>= 100 ng/mL.
Exclusion criteria
* Uncontrolled hypertension. * Requiring doses of EPO \> 10,000 IU/week. * Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study. * Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding). * Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study. * Androgen therapy in the 30 days immediately prior to randomisation in the study. * Known Human Immunodeficiency Virus(HIV)infection. * History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks | Baseline and 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL | week 16 and 24 | 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. |
| Change From Baseline in Hematocrits at 16 and 24 Weeks | Baseline and Weeks 16 and 24 | 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. |
Countries
Austria, Belgium, France, Germany, Italy, Spain, United Kingdom
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. Not enough subjects completed the study to do any efficacy analyses.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Dynepo (Epoetin Delta)-Naive Once-weekly (QW) Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW) | 98 |
| Dynepo-naive Twice-weekly (BIW) EPO-naive subjects receiving Epoetin delta twice weekly (BIW) | 107 |
| Dynepo Once Every 2 Weeks (Q2W) EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W) | 100 |
| Dynepo QW EPO stable subjects receiving Epoetin delta once weekly (QW) | 102 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 7 | 2 | 2 |
| Overall Study | Death | 3 | 2 | 2 | 2 |
| Overall Study | Kidney transplant | 1 | 0 | 1 | 3 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 0 |
| Overall Study | Study terminated | 47 | 54 | 16 | 21 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Dynepo (Epoetin Delta)-Naive Once-weekly (QW) | Total | Dynepo-naive Twice-weekly (BIW) | Dynepo QW | Dynepo Once Every 2 Weeks (Q2W) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 61 Participants | 252 Participants | 72 Participants | 67 Participants | 52 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 155 Participants | 35 Participants | 35 Participants | 48 Participants |
| Age, Continuous | 66.2 years STANDARD_DEVIATION 14.97 | 65.7 years STANDARD_DEVIATION 14.33 | 67.0 years STANDARD_DEVIATION 12.45 | 65.5 years STANDARD_DEVIATION 16.04 | 64.2 years STANDARD_DEVIATION 13.86 |
| Region of Enrollment Australia | 19 Participants | 54 Participants | 22 Participants | 6 Participants | 7 Participants |
| Region of Enrollment Austria | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Belgium | 2 Participants | 27 Participants | 2 Participants | 11 Participants | 12 Participants |
| Region of Enrollment France | 6 Participants | 25 Participants | 8 Participants | 3 Participants | 8 Participants |
| Region of Enrollment Germany | 15 Participants | 60 Participants | 16 Participants | 14 Participants | 15 Participants |
| Region of Enrollment Hungary | 8 Participants | 17 Participants | 8 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Italy | 5 Participants | 73 Participants | 5 Participants | 35 Participants | 28 Participants |
| Region of Enrollment Latvia | 14 Participants | 38 Participants | 16 Participants | 4 Participants | 4 Participants |
| Region of Enrollment Lithuania | 10 Participants | 19 Participants | 9 Participants | 0 Participants | 0 Participants |
| Region of Enrollment New Zealand | 3 Participants | 10 Participants | 3 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Spain | 3 Participants | 32 Participants | 2 Participants | 14 Participants | 13 Participants |
| Region of Enrollment United Kingdom | 10 Participants | 48 Participants | 15 Participants | 12 Participants | 11 Participants |
| Sex: Female, Male Female | 45 Participants | 160 Participants | 41 Participants | 41 Participants | 33 Participants |
| Sex: Female, Male Male | 53 Participants | 247 Participants | 66 Participants | 61 Participants | 67 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 | 59 / 98 | 50 / 107 | 44 / 100 | 44 / 102 |
| serious Total, serious adverse events | 15 / 98 | 23 / 107 | 23 / 100 | 20 / 102 |
Outcome results
Primary
Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks
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.
Time frame: Baseline and 24 weeks
Population: 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.
Secondary
Change From Baseline in Hematocrits at 16 and 24 Weeks
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.
Time frame: Baseline and Weeks 16 and 24
Population: 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.
Secondary
Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL
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.
Time frame: week 16 and 24
Population: 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.