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Study Complete
Sponsor ID
20070211

European Union registry in paediatric chronic kidney disease patients looking at safety and usage patterns of Darbepoetin Alfa

Sponsor ID
20070211
Clinicaltrials.gov ID
NCT00838097
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
darbepoetin alfa
Type
Observational
Masking
N/A
Enrollment
321
Additional Study Details

Protocol Summary

Primary Outcome Measures

To assess the long-term safety of darbepoetin alfa therapy in paediatric subjects with chronic kidney disease receiving or not receiving dialysis, as determined by the evaluation of incidence rates of SAEs, SADRs and EMIs

Timeframe: 2 years

Secondary Outcome Measures

To assess the usage pattern of darbepoetin alfa in the Chronic Kidney Disease paediatric patient population, haemoglobin and selected related laboratory values over time, and non serious adverse drug reactions

Timeframe: 2 years

Locations

No locations found.
Study Info
Age
0 - 16 Years
Condition
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Feb 2008 - Feb 2013
    Inclusion and Exclusion Criteria
    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