NCT02185911

Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 308 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Anaemia
• Chronic Kidney Disease (CKD)

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-07-10
• Last updated: 2016-03-08

Locations

40 sites across 8 countries: Austria, Bulgaria, Czechia, Greece, Hungary, Italy, Poland, Spain