Clinical trial NCT02191150: Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
Official title: Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaemia
Keywords: Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises prevalent haemodialysis (HD) patients treated at EU and Australian dialysis clinics after September 2008. Eligible patients will have received treatment with darbepoetin alfa for at least 26 weeks prior to being converted to an EMA/TGA-approved epoetin alfa biosimilar. At each participating study site, all potentially eligible patients are to be considered for enrolment.

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

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Haemoglobin Concentration
timeFrame: Duration of observation period -52 weeks
Secondary outcomes:
measure: ESA Doses
timeFrame: Duration of observation period -52 weeks
measure: Dose ratio
timeFrame: Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
measure: Dose ratio
timeFrame: Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
measure: Haemoglobin excursions
timeFrame: Duration of observation period -52 weeks
measure: Haemglobin within range
timeFrame: Duration of observation period -52 weeks
measure: TSAT, ferritin and albumin values
timeFrame: Duration of observation period -52 weeks
measure: Iron Use
timeFrame: Duration of observation period -52 weeks
measure: Red cell transfusions (including number of units transfused)
timeFrame: Duration of observation period -52 weeks
measure: Hospitalisations (including primary cause)
timeFrame: Duration of observation period -52 weeks
Other outcomes:
measure: Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies
timeFrame: Duration of 52-week observation period
Locations:
city: Herston
country: Australia
facility: Research Site
state: Queensland
city: Nambour
country: Australia
facility: Research Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Research Site
state: Queensland
city: Burgas
country: Bulgaria
facility: Research Site
city: Lemgo
country: Germany
facility: Research Site
city: Lich
country: Germany
facility: Research Site
city: Minden
country: Germany
facility: Research Site
city: Egaleo, Athens
country: Greece
facility: Research Site
city: Egaleo
country: Greece
facility: Research Site
city: Kallithea, Athens
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Milazzo ME
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Chojnice
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Rybnik
country: Poland
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
state: Andalucía
city: Zamora
country: Spain
facility: Research Site
state: Castilla León
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: