Study Complete
Sponsor ID
20120126
TRANSFORM - Observational cohort study of darbepoetin alfa use in European Union (EU) hemodialysis patients switched from PEG epoetin betaTRANSFORM
Study Details
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).
Protocol Summary
Primary Outcome Measures
Haemoglobin concentration
Timeframe: Up to 40 weeks
Secondary Outcome Measures
Measure all doses of PEG epoetin beta from the start of the observation period for 14 weeks.
Timeframe: Up to 14 weeks
Measure the doses of darbepoetin alfa from the switch date for up to 26 weeks
Timeframe: Up to 26 weeks from date of switch from Mircera to darbepoetin alfa, to the end of the observation peiod.
Dose ratio measured at the time of switch from PEG epoetin beta to darbepoetin alfa
Timeframe: Week 14
Haemoglobin concentration rate of rise
Timeframe: Up to 40 weeks
Haemoglobin excursions
Timeframe: Up to 40 weeks
Locations
Location
Research Site
Edegem, Belgium, 2650
Status
Completed
Location
Research Site
Arnhem, Netherlands, 6815 AD
Status
Completed
Location
Research Site
Blois, France, 41000
Status
Completed
Location
Research Site
Boulogne sur Mer, France, 62200
Status
Completed
Location
Research Site
Essey lès Nancy, France, 54270
Status
Completed
Location
Research Site
Grabels, France, 34790
Status
Completed
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