Study of Haemodialysis Patients Switching From Aranesp to Biosimilar

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

Detailed Description
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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.

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

Conditions
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Anaemia

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients with CKD | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.