Anemia, Kidney Diseases, Kidney Failure, Chronic, Renal Failure, Chronic
Conditions
Brief summary
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect & describe less common adverse drug reactions, and to summarise DYNEPO drug utilisation.
Interventions
dose, dose frequency, route of administration (iv or sc) and duration will be determined by the investigator according to their normal prescribing habits, as this is an observational study
Sponsors
Shire
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Adult patients must have established Chronic Kidney Disease (CKD) and be willing and able to provide written informed consent. * Patients must already be receiving DYNEPO treatment at time of study entry. * Patients who are likely to receive DYNEPO for at least 1 year.
Exclusion criteria
* Known intolerance to EPO of any of its excipients * Known of suspected Pure Red Cell Aplasia (PRCA)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo | up to 3 years | 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. |
Countries
Germany
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
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study terminated | 3 |
Baseline characteristics
| Characteristic | Dynepo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 57.0 years FULL_RANGE 0 |
| Region of Enrollment Germany | 3 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo
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.
Time frame: up to 3 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.