European Union Registry in Paediatric Chronic Kidney Disease Patients Looking at Safety and Usage Patterns of Darbepoetin Alfa
This study has been completed.
Information provided by (Responsible Party):
First received: February 5, 2009
Last updated: February 27, 2014
Last verified: February 2014
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.
Chronic Kidney Disease
|Study Type:||Observational [Patient Registry]|
|Study Design:||Time Perspective: Prospective|
|Target Follow-Up Duration:||2 Years|
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Amgen:
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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
Contacts and Locations