Study of Haemodialysis Patients Switching From Aranesp to Biosimilar

NCT02191150 | Completed

• 1 other identifier: 20130300
• Study Type: observational
• Target: 272
• Locations: 7 countries
• Sites: 23

Brief Summary

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

Conditions

Anaemia

Keywords

Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.

Outcome Measures

Primary Outcomes (1)

• Haemoglobin Concentration

  Mean haemoglobin concentration over time

  Duration of observation period -52 weeks

Secondary Outcomes (9)

• ESA Doses

  Duration of observation period -52 weeks

• Dose ratio

  Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)

• Dose ratio

  Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)

• Haemoglobin excursions

  Duration of observation period -52 weeks

• Haemglobin within range

  Duration of observation period -52 weeks

Other Outcomes (1)

• Number of Subjects with PRCA testing and incidence of neutralizing anti-erythropoietin antibodies

  Duration of 52-week observation period

Study Arms (1)

Cohort 1

Patients with CKD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (23)

Research Site

Herston, Queensland, 4029, Australia

Location

Research Site

Nambour, Queensland, 4560, Australia

Location

Research Site

Woolloongabba, Queensland, 4102, Australia

Location

Research Site

Burgas, 8000, Bulgaria

Location

Research Site

Lemgo, 32657, Germany

Location

Research Site

Lich, 35423, Germany

Location

Research Site

Minden, 32429, Germany

Location

Research Site

Aigáleo, 12242, Greece

Location

Research Site

Egaleo, Athens, 12244, Greece

Location

Research Site

Kallithea, Athens, 17676, Greece

Location

Research Site

Larissa, 41335, Greece

Location

Research Site

Pátrai, 26225, Greece

Location

Research Site

Pátrai, 26500, Greece

Location

Research Site

Milazzo ME, 98057, Italy

Location

Research Site

Pisa, 56124, Italy

Location

Research Site

Chojnice, 89-600, Poland

Location

Research Site

Gdansk, 80-952, Poland

Location

Research Site

Krakow, 31-501, Poland

Location

Research Site

Lublin, 20-954, Poland

Location

Research Site

Poznan, 60-355, Poland

Location

Research Site

Rybnik, 44-200, Poland

Location

Research Site

Jaén, Andalusia, 23007, Spain

Location

Research Site

Zamora, Castille and León, 49022, Spain

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 16, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

AU (3); DE (3); BU (1); IT (2); PL (6); GR (6); ES (2)