TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta (TRANSFORM)
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| ClinicalTrials.gov Identifier: NCT01997892 |
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Recruitment Status :
Completed
First Posted : November 28, 2013
Results First Posted : May 15, 2014
Last Update Posted : June 9, 2014
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Brief 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).
| Condition or disease |
|---|
| Anemia |
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 Type : | Observational |
| Actual Enrollment : | 1027 participants |
| Observational Model: | Cohort |
| Official Title: | TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera |
| Study Start Date : | August 2012 |
| Actual Primary Completion Date : | June 2013 |
| Actual Study Completion Date : | July 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Dialysis
Drug Information available for:
Darbepoetin Alfa
| Group/Cohort |
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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.
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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch [ Time Frame: Month -3, Month -2, Month -1 ]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.
- Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period [ Time Frame: Month 1, 2, 3, 4, 5 and 6 ]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.
- Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa [ Time Frame: Week -1 and Week 1 ]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).
- Hemoglobin Concentration Rate of Change by Period [ Time Frame: Thre months prior to switch and 6 months after the switch ]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.
- Percentage of Participants With Hemoglobin Excursions [ Time Frame: Month -3, -2, -1, 1, 2, 3, 4, 5 and 6 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
CKD dialysed patients from EU centers treated with PEG epoetin beta for a minimum of 14weeks prior to switching to darbepoetin alfa.
Criteria
Inclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997892
Locations
| Belgium | |
| Research Site | |
| Edegem, Belgium, 2650 | |
| France | |
| Research Site | |
| Antony, France, 92160 | |
| Research Site | |
| Aurillac, France, 15000 | |
| Research Site | |
| Blois, France, 41000 | |
| Research Site | |
| Boulogne sur Mer, France, 62200 | |
| Research Site | |
| Béziers, France, 34500 | |
| Research Site | |
| Cahors, France, 46000 | |
| Research Site | |
| Essey lès Nancy, France, 54270 | |
| Research Site | |
| Grabels, France, 34790 | |
| Research Site | |
| La Roche sur Yon Cedex 9, France, 85925 | |
| Research Site | |
| La Réunion, France, 97420 | |
| Research Site | |
| Libourne, France, 33505 | |
| Research Site | |
| Lille Cedex, France, 59800 | |
| Research Site | |
| Metz, France, 57000 | |
| Research Site | |
| Paris, France, 75015 | |
| Research Site | |
| Paris, France, 75016 | |
| Research Site | |
| Poitiers, France, 86021 | |
| Research Site | |
| Saint Nazaire, France, 44606 | |
| Research Site | |
| Saint Pierre, France, 97410 | |
| Research Site | |
| Saint Priest en Jarez, France, 42270 | |
| Research Site | |
| Saint-Denis de la Réunion, France, 97400 | |
| Research Site | |
| Strasbourg, France, 67000 | |
| Research Site | |
| Vandoeuvre Les Nancy Cedex, France, 54504 | |
| Germany | |
| Research Site | |
| Kiel, Germany, 24106 | |
| Research Site | |
| Nordhorn, Germany, 48527 | |
| Greece | |
| Research Site | |
| Athens, Greece, 11528 | |
| Research Site | |
| Athens, Greece, 15562 | |
| Netherlands | |
| Research Site | |
| Arnhem, Netherlands, 6815 AD | |
| Spain | |
| Research Site | |
| Ribeira, Galicia, Spain, 15993 | |
| Research Site | |
| Santiago de Compostela, Galicia, Spain, 15701 | |
| Research Site | |
| Santiago de Compostela, Galicia, Spain, 15706 | |
| Switzerland | |
| Research Site | |
| Sion, Switzerland, 1950 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01997892 |
| Other Study ID Numbers: |
20120126 |
| First Posted: | November 28, 2013 Key Record Dates |
| Results First Posted: | May 15, 2014 |
| Last Update Posted: | June 9, 2014 |
| Last Verified: | June 2014 |
Keywords provided by Amgen:
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CKD Darbepoetin Alfa Dialysis |
Hemodialysis Anemia Peg epoetin beta |
Additional relevant MeSH terms:
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Anemia Hematologic Diseases |