Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
NCT ID: NCT02191150
Last Updated: 2016-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
272 participants
OBSERVATIONAL
2014-06-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RETROSPECTIVE
Study Groups
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Cohort 1
Patients with CKD
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Herston, Queensland, Australia
Research Site
Nambour, Queensland, Australia
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
Research Site
Larissa, , Greece
Research Site
Pátrai, , Greece
Research Site
Pátrai, , Greece
Research Site
Milazzo ME, , Italy
Research Site
Pisa, , Italy
Research Site
Chojnice, , Poland
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Rybnik, , Poland
Research Site
Jaén, Andalusia, Spain
Research Site
Zamora, Castille and León, Spain
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20130300
Identifier Type: -
Identifier Source: org_study_id
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