Trials / Completed
CompletedNCT02191150
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 272 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.
Detailed 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.
Conditions
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-04-01
- Completion
- 2015-05-01
- First posted
- 2014-07-16
- Last updated
- 2016-02-08
Locations
23 sites across 7 countries: Australia, Bulgaria, Germany, Greece, Italy, Poland, Spain
Source: ClinicalTrials.gov record NCT02191150. Inclusion in this directory is not an endorsement.