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Clinical Trial Summary

The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.


Clinical Trial Description

Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This study will look at the retrospective data of patients that have switched from Darbepoetin Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar. Data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the study will be published. ;


Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT02191150
Study type Observational
Source Amgen
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date May 2015

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