A Non-Interventional, Post-Authorisation Study to Assess Adverse Events and Drug Utilisation Among Chronic Kidney Disease Patients Treated With DYNEPO

Shire2 sites in 1 country3 target enrollmentApril 25, 2008

ConditionsAnemia Kidney Diseases Renal Failure, Chronic Kidney Failure, Chronic

DrugsDYNEPO (epoetin delta)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anemia
Sponsor: Shire
Enrollment: 3
Locations: 2
Primary Endpoint: Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 25, 2008

End Date

July 30, 2008

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Assess the Incidence and Severity of All Predefined Cardiovascular Events in Subjects Treated With Dynepo

Time Frame: 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.