Status:
COMPLETED
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
Lead Sponsor:
Amgen
Conditions:
Anaemia
Eligibility:
All Genders
18+ years
Brief 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 approv...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients ≥18 years of age
- Patients with CKD on haemodialysis and fulfilling the following:
- Received HD for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar
- Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted)
- Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment
- Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment
- Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch
- Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in the 12 weeks prior to switch
- Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements
- Exclusion Criteria:
- Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar
- More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar
- Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar
- Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.
Exclusion
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT02191150
Start Date
June 1 2014
End Date
May 1 2015
Last Update
February 8 2016
Active Locations (23)
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1
Research Site
Herston, Queensland, Australia, 4029
2
Research Site
Nambour, Queensland, Australia, 4560
3
Research Site
Woolloongabba, Queensland, Australia, 4102
4
Research Site
Burgas, Bulgaria, 8000