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

Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar

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

Study Overview

• Status: Completed
• Conditions: Anaemia

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.

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Research Site
    • Nambour, Queensland, Australia, 4560
      • Research Site
    • Woolloongabba, Queensland, Australia, 4102
      • Research Site
• Bulgaria
  • Burgas, Bulgaria, 8000
    • Research Site
• Germany
  • Lemgo, Germany, 32657
    • Research Site
  • Lich, Germany, 35423
    • Research Site
  • Minden, Germany, 32429
    • Research Site
• Greece
  • Egaleo, Greece, 12242
    • Research Site
  • Egaleo, Athens, Greece, 12244
    • Research Site
  • Kallithea, Athens, Greece, 17676
    • Research Site
  • Larissa, Greece, 41335
    • Research Site
  • Patra, Greece, 26500
    • Research Site
  • Patra, Greece, 26225
    • Research Site
• Italy
  • Milazzo ME, Italy, 98057
    • Research Site
  • Pisa, Italy, 56124
    • Research Site
• Poland
  • Chojnice, Poland, 89-600
    • Research Site
  • Gdansk, Poland, 80-952
    • Research Site
  • Krakow, Poland, 31-501
    • Research Site
  • Lublin, Poland, 20-954
    • Research Site
  • Poznan, Poland, 60-355
    • Research Site
  • Rybnik, Poland, 44-200
    • Research Site
• Spain
  • Andalucía
    • Jaen, Andalucía, Spain, 23007
      • Research Site
  • Castilla León
    • Zamora, Castilla León, Spain, 49022
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; Patients with CKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin Concentration	Mean haemoglobin concentration over time	Duration of observation period -52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESA Doses	Doses of ESA over time.	Duration of observation period -52 weeks
Dose ratio	Dose ratio between the start of the post-switch observation period and pre-switch	Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
Dose ratio	Dose ratio between the end of the post-switch observation period and pre-switch	Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
Haemoglobin excursions	Haemoglobin excursions (<10/dL and >12g/dL)	Duration of observation period -52 weeks
Haemglobin within range	Haemoglobin in the range 10-12g/dL over time	Duration of observation period -52 weeks
TSAT, ferritin and albumin values	TSAT, ferritin and albumin over time	Duration of observation period -52 weeks
Iron Use	Iron use (dose/route) over time	Duration of observation period -52 weeks
Red cell transfusions (including number of units transfused)	Red cell transfusions (including number of units transfused)	Duration of observation period -52 weeks
Hospitalisations (including primary cause)	Hospitalisations (including primary cause)	Duration of observation period -52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies	Pure Red Cell Aplasia (PRCA) test and results	Duration of 52-week observation period

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 7, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 5, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 20130300