To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).
This is a multi-centre, observational cohort study of EU hemodialysis patients whose erythropoiesis stimulating agent (ESA) therapy has been switched from PEG epoetin beta to darbepoetin alfa. Data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.
Study Type
OBSERVATIONAL
Enrollment
1,027
Research Site
Edegem, Belgium
Hemoglobin Concentration at Monthly Intervals
Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.
Time frame: Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)
PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch
Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses \>150 μg have been excluded as they were deemed infeasible values derived by the algorithm.
Time frame: Month -3, Month -2, Month -1
Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period
Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses \>150 μg have been excluded as they were deemed infeasible values derived by the algorithm.
Time frame: Month 1, 2, 3, 4, 5 and 6
Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa
Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (μg darbepoetin alfa per 1 μg pegylated-epoetin beta).
Time frame: Week -1 and Week 1
Hemoglobin Concentration Rate of Change by Period
The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant.
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Research Site
Antony, France
Research Site
Aurillac, France
Research Site
Béziers, France
Research Site
Blois, France
Research Site
Boulogne-sur-Mer, France
Research Site
Cahors, France
Research Site
Essey-lès-Nancy, France
Research Site
Grabels, France
Research Site
La Réunion, France
...and 22 more locations
Time frame: Thre months prior to switch and 6 months after the switch
Percentage of Participants With Hemoglobin Excursions
The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods.
Time frame: Month -3, -2, -1, 1, 2, 3, 4, 5 and 6