Status:
COMPLETED
European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
Lead Sponsor:
Amgen
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
Up to 16 years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00838097
Start Date
February 1 2008
End Date
February 1 2013
Last Update
August 1 2014
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