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

Amgen

Status: Completed

Conditions: Anaemia

Study type: Observational

Funder types: Industry

Identifiers

NCT02191150

20130300

Details and patient eligibility

About

The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.

Full description

Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This study will look at the retrospective data of patients that have switched from Darbepoetin Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar. Data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the study will be published.

Enrollment: 272 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

272 participants in 1 patient group

Cohort 1

Description:

Patients with CKD