European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa

A Prospective Registry Study Observing the Safety and Patterns of Use of Darbepoetin Alfa in EU Paediatric Chronic Kidney Disease Patients Receiving or Not Receiving Dialysis

This European study observes paediatric patients with Chronic Kidney Disease using Darbepoetin Alfa to assess the drug's long term safety and profile the patterns of its use within this population.

Inclusion Criteria:

• Anaemia attributed to Chronic Kidney Disease (CKD)
• Sixteen years of age or under
• Documented CKD as demonstrated by estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m² (Schwartz equation) for ≥3 months if not on dialysis, or: Receiving dialysis
• Treatment with darbepoetin alfa
• Documented informed consent by a parent or authorised individual, if required, and assent by the patient if appropriate

Exclusion Criteria:

• Active malignancy or current chemotherapy or radiation therapy
• Investigator unlikely to be able to obtain adequate follow-up information, or participant will not be available for follow-up assessment
• Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study; subject receiving other investigational agents