Study of Haemodialysis Patients Switching From Aranesp to Biosimilar

• Register: ClinicalTrials.gov
• Last refreshed on: 15 February 2016
• Main ID: NCT02191150
• Date of registration: 07/07/2014
• Prospective Registration: No
• Primary sponsor: Amgen
• Public title: Study of Haemodialysis Patients Switching From Aranesp to Biosimilar SHADE
• Scientific title: Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar
• Date of first enrolment: June 2014
• Target sample size: 272
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02191150
• Study type: Observational
• Study design: Time Perspective: Retrospective
• Phase: N/A

Countries of recruitment

Australia, Bulgaria, Germany, Greece, Italy, Poland, Spain

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anaemia

Primary Outcome(s)

Haemoglobin Concentration [Time Frame: Duration of observation period -52 weeks]

Secondary Outcome(s)

Red cell transfusions (including number of units transfused) [Time Frame: Duration of observation period -52 weeks]

Haemoglobin excursions [Time Frame: Duration of observation period -52 weeks]

Iron Use [Time Frame: Duration of observation period -52 weeks]

Dose ratio [Time Frame: Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)]

Dose ratio [Time Frame: Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)]

TSAT, ferritin and albumin values [Time Frame: Duration of observation period -52 weeks]

Haemglobin within range [Time Frame: Duration of observation period -52 weeks]

Hospitalisations (including primary cause) [Time Frame: Duration of observation period -52 weeks]

ESA Doses [Time Frame: Duration of observation period -52 weeks]

Secondary ID(s)

20130300

Source(s) of Monetary Support

Please refer to primary and secondary sponsors