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

Shire

Status: Terminated

Conditions: Anemia; Kidney Diseases; Renal Failure, Chronic; Kidney Failure, Chronic

Treatments: Drug: DYNEPO (epoetin delta)

Study type: Observational

Funder types: Industry

Identifiers

NCT00664066

SPD490-404

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Volunteers: No Healthy Volunteers

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)