AnaemiaSHADENCT02191150
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
An observational study of Anaemia, run by Amgen at 23 sites in 7 countries.
Trial summary
The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaemia
- How many people
- 272 participants
- Where
- 23 sitesin 7 countries
- Study dates
- Jun 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
23 sites in 7 countries.
23 sites in 7 countries
Greece6 sites
Research Site
Aigáleo, 12242
Research Site
Egaleo, Athens, 12244
Research Site
Kallithea, Athens, 17676
Research Site
Larissa, 41335
Research Site
Pátrai, 26225
Research Site
Pátrai, 26500
Poland6 sites
Research Site
Chojnice, 89-600
Research Site
Gdansk, 80-952
Research Site
Krakow, 31-501
Research Site
Lublin, 20-954
Research Site
Poznan, 60-355
Research Site
Rybnik, 44-200
Australia3 sites
Research Site
Herston, Queensland, 4029
Research Site
Nambour, Queensland, 4560
Research Site
Woolloongabba, Queensland, 4102
Germany3 sites
Research Site
Lemgo, 32657
Research Site
Lich, 35423
Research Site
Minden, 32429
Spain2 sites
Research Site
Jaén, Andalusia, 23007
Research Site
Zamora, Castille and León, 49022
About this study
Official title: 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.
Read the 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.
- Conditions
- Anaemia
- Keywords
- Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin Concentration
Mean haemoglobin concentration over time
Measured: Duration of observation period -52 weeks
Secondary outcomes (9)
ESA Doses
Doses of ESA over time.
Measured: Duration of observation period -52 weeks
Dose ratio
Dose ratio between the start of the post-switch observation period and pre-switch
Measured: 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
Measured: Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
Haemoglobin excursions
Haemoglobin excursions (<10/dL and >12g/dL)
Measured: Duration of observation period -52 weeks
Haemglobin within range
Haemoglobin in the range 10-12g/dL over time
Measured: Duration of observation period -52 weeks
TSAT, ferritin and albumin values
TSAT, ferritin and albumin over time
Measured: Duration of observation period -52 weeks
Iron Use
Iron use (dose/route) over time
Measured: Duration of observation period -52 weeks
Red cell transfusions (including number of units transfused)
Red cell transfusions (including number of units transfused)
Measured: Duration of observation period -52 weeks
Hospitalisations (including primary cause)
Hospitalisations (including primary cause)
Measured: Duration of observation period -52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191150
- Sponsor's protocol ID
- 20130300
- Acronym
- SHADE
- Status last verified
- Feb 2016
- First submitted
- 7 Jul 2014
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar
- ClinicalTrials.gov ID
- NCT02191150
- Acronym / sponsor ID
- SHADE / 20130300
- Conditions
- Anaemia
- Keywords
- Anaemia, Chronic Kidney Disease, Switching, Aranesp, Darbepoetin Alfa, Epoetin Alfa Biosimilars, Haemodialysis.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients with CKD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Patients ≥18 years of age
- Patients with CKD on haemodialysis and fulfilling the following:
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Haemoglobin Concentration
Time frame: Duration of observation period -52 weeks
Mean haemoglobin concentration over time
9 secondary outcomes
ESA Doses
Time frame: Duration of observation period -52 weeks
Dose ratio
Time frame: Start post-switch (weeks 1-4) and pre-switch (weeks -4--1)
Dose ratio
Time frame: Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1)
Haemoglobin excursions
Time frame: Duration of observation period -52 weeks
Haemglobin within range
Time frame: Duration of observation period -52 weeks
TSAT, ferritin and albumin values
Time frame: Duration of observation period -52 weeks
Iron Use
Time frame: Duration of observation period -52 weeks
Red cell transfusions (including number of units transfused)
Time frame: Duration of observation period -52 weeks
Hospitalisations (including primary cause)
Time frame: Duration of observation period -52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
23 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaemia, run by Amgen at 23 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Greece, Poland, Australia, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin Concentration (time frame: Duration of observation period -52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.