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

Amgen

Status: Completed

Conditions: Chronic Kidney Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00838097

20070211

Details and patient eligibility

About

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.

Enrollment: 321 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

321 participants in 1 patient group

Darbepoetin alfa

Description:

Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.