DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)

• Status: Terminated
• Trial end date: 2008-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Epoetin Alfa

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)