The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.
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 Type
OBSERVATIONAL
Enrollment
272
Research Site
Herston, Queensland, Australia
Research Site
Nambour, Queensland, Australia
Haemoglobin Concentration
Mean haemoglobin concentration over time
Time frame: Duration of observation period -52 weeks
ESA Doses
Doses of ESA over time.
Time frame: Duration of observation period -52 weeks
Dose ratio
Dose ratio between the start of the post-switch observation period and pre-switch
Time frame: Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
Dose ratio
Dose ratio between the end of the post-switch observation period and pre-switch
Time frame: Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
Haemoglobin excursions
Haemoglobin excursions (\<10/dL and \>12g/dL)
Time frame: Duration of observation period -52 weeks
Haemglobin within range
Haemoglobin in the range 10-12g/dL over time
Time frame: Duration of observation period -52 weeks
TSAT, ferritin and albumin values
TSAT, ferritin and albumin over time
Time frame: Duration of observation period -52 weeks
Iron Use
Iron use (dose/route) over time
Time frame: Duration of observation period -52 weeks
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Research Site
Woolloongabba, Queensland, Australia
Research Site
Burgas, Bulgaria
Research Site
Lemgo, Germany
Research Site
Lich, Germany
Research Site
Minden, Germany
Research Site
Aigáleo, Greece
Research Site
Egaleo, Athens, Greece
Research Site
Kallithea, Athens, Greece
...and 13 more locations
Red cell transfusions (including number of units transfused)
Red cell transfusions (including number of units transfused)
Time frame: Duration of observation period -52 weeks
Hospitalisations (including primary cause)
Hospitalisations (including primary cause)
Time frame: Duration of observation period -52 weeks