TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta

Amgen

Status: Completed

Conditions: Anemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01997892

20120126

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 1,027 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients >18 years of age. CKD diagnosis, receiving hemodialysis
• Received PEG epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.

Trial design

1,027 participants in 1 patient group

Chronic Kidney Disease (CKD)

Description:

Participants with CKD on dialysis and treated with PEG epoetin beta for a minimum of 14 weeks immediately prior to being switched to darbepoetin alfa.