Study of Haemodialysis Patients Switching From Aranesp to Biosimilar

Completed

• Conditions: Anaemia

• Registration Number: NCT02191150
• Lead Sponsor: Amgen

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Primary Completion: 2015-04
• Study Completion: 2015-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-05
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemoglobin Concentration	Duration of observation period -52 weeks	Mean haemoglobin concentration over time

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zamora, Castilla León, Spain