An observational study in Anaemia and Chronic Kidney Disease (CKD), sponsored by Amgen. Completed at 40 sites in 8 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Amgen · Observational
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 308 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
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Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
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The study population comprises CKD patients not on dialysis, ESA-naïve at time of initiation of darbepoetin alfa QM, and treated at nephrology clinics in EU and Australia from 01 May 2013. Eligible patients will have received at least three consecutive doses of darbepoetin alfa for correction of anaemia at a QM dosing interval. At each participating study site, all potentially elgible patients are to be considered for enrolment.
Patients with CKD:
Exclusion Criteria:
Patients with CKD
Monthly Haemoglobin values
Monthly Hb within 10-12g/dL during the 32 weeks post initiation of darbepoetin alfa QM
Time frame: During the 32 weeks post initiation of darbepoetin alfa QM
Doses of darbepoetin alfa/other ESAs over time
Doses of darbepoetin alfa/other ESAs over time (dose, route, frequency)
Time frame: Throughout the 46 week observation period
Haemoglobin values
Haemoglobin over the observation period
Time frame: Throughout the 46 week observation period
Change in Haemoglobin values
Change in haemoglobin from baseline
Time frame: Throughout the 46 week observation period
Increase in haemoglobin from baseline
Increase in haemoglobin of at least 1g/dL from baseline
Time frame: Throughout the 46 week observation period
Haemoglobin excursions
Haemoglobin excursions (\<10,\>12 g/dL) over the observation period
Time frame: Throughout the 46 week observation period
First haemoglobin within 10-12g/dL
Time from initiation of darbepoetin alfa QM to first haemoglobin within 10-12g/dL
Time frame: During the 32 weeks post initiation of darbepoetin alfa QM
first dose frequency change after third dose of darbepoetin alfa QM
Time from third dose of darbepoetin alfa at QM dosing frequency to first frequency change
Time frame: During the 32 weeks post initiation of darbepoetin alfa QM
Subjects remaining on darbepoetin alfa QM
Remaining on darbepoetin alfa QM for the full 32 weeks post initiation
Time frame: During the 32 weeks post initiation of darbepoetin alfa QM
TSAT, ferritin and albumin values
TSAT, ferritin and albumin over the observation period
Time frame: Throughout the 46 week observation period
Iron Use
Iron use (dose/route) over the observation period
Time frame: Throughout the 46 week observation period
Transfusions
Transfusions over the observation period (number of tranfusions and the number of units transfused)
Time frame: Throughout the 46 week observation period
Hospitalisations
Hospitalisations (duration and primary cause) over the observation period
Time frame: Throughout the 46 week observation period
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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