Status:
COMPLETED
Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis
Lead Sponsor:
Amgen
Conditions:
Anaemia
Chronic Kidney Disease (CKD)
Eligibility:
All Genders
18-100 years
Brief Summary
To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM
Detailed Description
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 correct...
Eligibility Criteria
Inclusion
- Patients ≥18 years of age.
- Patients with CKD:
- Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency.
- Hb \<10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing.
- Commenced darbepoetin alfa at QM dosing frequency during or after August 2013.
- 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.
- Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.
Exclusion
- Treatment with an ESA within 14 weeks prior to initiation of darbepoetin alfa.
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT02185911
Start Date
June 1 2014
End Date
April 1 2015
Last Update
March 8 2016
Active Locations (40)
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1
Research Site
Feldkirch, Austria, 6807
2
Research Site
Linz, Austria, 4020
3
Research Site
Vienna, Austria, 1220
4
Research Site
Dobrich, Bulgaria, 9300