AnemiaTRANSFORMNCT01997892
TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta
An observational study of Anemia, run by Amgen at 32 sites in 7 countries.
Trial summary
To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- How many people
- 1,027 participants
- Where
- 32 sitesin 7 countries
- Study dates
- Aug 2012to Jul 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: CKD dialysed patients from EU centers treated with PEG epoetin beta for a minimum of 14weeks prior to switching to darbepoetin alfa.
Who may be able to join
- Patients >18 years of age. CKD diagnosis, receiving hemodialysis
- Received PEG epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.
Who cannot join
None listed.
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
France22 sites
Research Site
Antony, 92160
Research Site
Aurillac, 15000
Research Site
Béziers, 34500
Research Site
Blois, 41000
Research Site
Boulogne-sur-Mer, 62200
Research Site
Cahors, 46000
Research Site
Essey-lès-Nancy, 54270
Research Site
Grabels, 34790
Research Site
La Réunion, 97420
Research Site
La Roche-sur-Yon, 85925
Research Site
Libourne, 33505
Research Site
Lille, 59800
Research Site
Metz, 57000
Research Site
Paris, 75015
Research Site
Paris, 75016
Research Site
Poitiers, 86021
Research Site
Saint-Denis de La Réunion, 97400
Research Site
Saint-Nazaire, 44606
Research Site
Saint-Pierre, 97410
Research Site
Saint-Priest-en-Jarez, 42270
Research Site
Strasbourg, 67000
Research Site
Vandœuvre-lès-Nancy, 54504
Spain3 sites
Research Site
Ribeira, Galicia, 15993
Research Site
Santiago de Compostela, Galicia, 15701
Research Site
Santiago de Compostela, Galicia, 15706
About this study
Official title: TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera
To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).
Read the detailed description
This is a multi-centre, observational cohort study of EU hemodialysis patients whose erythropoiesis stimulating agent (ESA) therapy has been switched from PEG epoetin beta to darbepoetin alfa. Data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.
- Conditions
- Anemia
- Keywords
- CKD, Darbepoetin Alfa, Dialysis, Hemodialysis, Anemia, Peg epoetin beta
- Medical subject headings
- Anemia
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 |
|---|---|---|
| Chronic Kidney Disease (CKD) | Participants with CKD on dialysis and treated with PEG epoetin beta for a minimum of 14 weeks immediately prior to being switched to darbepoetin alfa. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Concentration at Monthly Intervals
Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.
Measured: Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)
Secondary outcomes (5)
PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch
Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.
Measured: Month -3, Month -2, Month -1
Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period
Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.
Measured: Month 1, 2, 3, 4, 5 and 6
Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa
Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (μg darbepoetin alfa per 1 μg pegylated-epoetin beta).
Measured: Week -1 and Week 1
Hemoglobin Concentration Rate of Change by Period
The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant.
Measured: Thre months prior to switch and 6 months after the switch
Percentage of Participants With Hemoglobin Excursions
The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods.
Measured: Month -3, -2, -1, 1, 2, 3, 4, 5 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Observational model
- Cohort
- Enrolment
- 1,027 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
- NCT01997892
- Sponsor's protocol ID
- 20120126
- Acronym
- TRANSFORM
- Status last verified
- Jun 2014
- First submitted
- 18 Dec 2012
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Adv Ther. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Epub 2014 Nov 1.
PubMed 25367412
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera
- ClinicalTrials.gov ID
- NCT01997892
- Acronym / sponsor ID
- TRANSFORM / 20120126
- Conditions
- Anemia
- Keywords
- CKD, Darbepoetin Alfa, Dialysis, Hemodialysis, Anemia, Peg epoetin beta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Posted 15 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).
Detailed description
This is a multi-centre, observational cohort study of EU hemodialysis patients whose erythropoiesis stimulating agent (ESA) therapy has been switched from PEG epoetin beta to darbepoetin alfa. Data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease (CKD) | – | –Participants with CKD on dialysis and treated with PEG epoetin beta for a minimum of 14 weeks immediately prior to being switched to darbepoetin alfa. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CKD dialysed patients from EU centers treated with PEG epoetin beta for a minimum of 14weeks prior to switching to darbepoetin alfa.
Key inclusion criteria (2 listed)
- Patients >18 years of age. CKD diagnosis, receiving hemodialysis
- Received PEG epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.
Key exclusion criteria (0 listed)
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
Hemoglobin Concentration at Monthly Intervals
Time frame: Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)
Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.
5 secondary outcomes
PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch
Time frame: Month -3, Month -2, Month -1
Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period
Time frame: Month 1, 2, 3, 4, 5 and 6
Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa
Time frame: Week -1 and Week 1
Hemoglobin Concentration Rate of Change by Period
Time frame: Thre months prior to switch and 6 months after the switch
Percentage of Participants With Hemoglobin Excursions
Time frame: Month -3, -2, -1, 1, 2, 3, 4, 5 and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25367412Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Adv Ther. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Epub 2014 Nov 1.
- 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
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Amgen at 32 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 2 inclusion and 0 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France, Spain, Germany, Greece, Belgium 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?
Yes. Results are posted in the registry (first posted 15 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin Concentration at Monthly Intervals (time frame: Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997892, which also lists 1 linked publication.
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 9 Jun 2014.