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Observational Study of Correction of Anaemia With Darbepoetin Alfa at Monthly Dose Frequency in EU and Australian Patients With Chronic Kidney Disease Not on Dialysis
To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM
Darbepoetin alfa (Aranesp) is a long-acting ESA approved for treatment of anaemia in CKD patients, and may be administered once a week (QW), once every two weeks (Q2W) or once a month (QM) for correction and for maintenance in CKD patients not on dialysis. Prescribing information for darbepoetin alfa was updated in August 2013 (in EU and Australia), to incorporate the option for correction at QM dosing frequency in CKD patients not on dialysis. There is very little published literature describing QM correction in a real-world setting. Data obtained from this study are intended to contribute to filling a literature gap and to provide a robust source of information for physicians.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
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
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Start Date
June 1, 2014
Primary Completion Date
April 1, 2015
Completion Date
April 1, 2015
Last Updated
March 8, 2016
308
ACTUAL participants
Lead Sponsor
Amgen
NCT06884280
NCT07082205
Data Source & Attribution
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