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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

321 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Darbepoetin alfa

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

No interventions assigned to this group

Eligibility Criteria

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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

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No