Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis
NCT ID: NCT02185911
Last Updated: 2016-03-08
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
308 participants
OBSERVATIONAL
2014-06-30
2015-04-30
Brief Summary
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Detailed Description
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Data obtained from this study are intended to contribute to filling a literature gap and to provide a robust source of information for physicians.
Conditions
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Study Design
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COHORT
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
2. Patients with CKD:
1. Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency.
2. Hb \<10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing.
3. Commenced darbepoetin alfa at QM dosing frequency during or after August 2013.
4. Received at least three consecutive doses of darbepoetin alfa at QM dosing frequency, being the initiation dose and two further doses at QM dosing frequency.
3. Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.
Exclusion Criteria
2. Patient was enrolled in an interventional device or drug study at any time during the 46-week data observation period or within 30 days prior to commencement of the data observtion period.
18 Years
100 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
Feldkirch, , Austria
Research Site
Linz, , Austria
Research Site
Vienna, , Austria
Research Site
Dobrich, , Bulgaria
Research Site
Montana, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
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Sofia, , Bulgaria
Research Site
Varna, , Bulgaria
Research Site
Vratsa, , Bulgaria
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Brno, , Czechia
Research Site
Havlíčkův Brod, , Czechia
Research Site
Nové Město na Moravě, , Czechia
Research Site
Třebíč, , Czechia
Research Site
Athens, , Greece
Research Site
Athens, , Greece
Research Site
Pátrai, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Thessaloniki, , Greece
Research Site
Baja, , Hungary
Research Site
Kecskemét, , Hungary
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Szeged, , Hungary
Research Site
Szigetvár, , Hungary
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Szombathely, , Hungary
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Zalaegerszeg, , Hungary
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Albano Laziale RM, , Italy
Research Site
Lodz, , Poland
Research Site
Lodz, , Poland
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Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Sieradz, , Poland
Research Site
Stalowa Wola, , Poland
Research Site
Córdoba, Andalusia, Spain
Research Site
Badalona, Catalonia, Spain
Research Site
Barcelona, Catalonia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Valencia, Valencia, Spain
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20130301
Identifier Type: -
Identifier Source: org_study_id
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