Study of Haemodialysis Patients Switching From Aranesp to Biosimilar (SHADE)

Inclusion Criteria

• Patients ≥18 years of age

• Patients with CKD on haemodialysis and fulfilling the following:

  • Received HD for at least 26 weeks prior to switching from treatment with darbepoetin alfa to treatment with an EMA/TGA-approved epoetin alfa biosimilar
  • Received darbepoetin alfa treatment i.v. for at least 26 weeks immediately prior to switching to an EMA/TGA-approved epoetin alfa biosimilar (breaks due to treatment being intentionally withheld are permitted)
  • Switched from darbepoetin alfa treatment to an EMA/TGA-approved epoetin alfa biosimilar at least 26 weeks prior to enrolment
  • Received at least one dose of an EMA/TGA-approved epoetin alfa biosimilar after switching from darbepoetin alfa treatment
• Mean monthly Hb 10-12g/dL in the 12 weeks prior to switch
• Stable darbepoetin alfa dose (i.e. no more than one increment or decrement of PFS) in the 12 weeks prior to switch
• Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements

Exclusion Criteria:

• Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar
• More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar
• Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar
• Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.