Study Complete
Sponsor ID
20120126

TRANSFORM - Observational cohort study of darbepoetin alfa use in European Union (EU) hemodialysis patients switched from PEG epoetin betaTRANSFORM

Sponsor ID
20120126
Clinicaltrials.gov ID
NCT01997892
EUCTIS ID
N/A
EudraCT ID
N/A

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).

Additional Study Details

Phase
N/A
Product
darbepoetin alfa
Type
Observational
Masking
N/A
Enrollment
1027
Additional Study Details

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
Status
Contact Us
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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