Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Concentration at Monthly Intervals | Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period. | Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
CKD dialysed patients from EU centers treated with PEG epoetin beta for a minimum of 14weeks prior to switching to darbepoetin alfa.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Edegem | 2650 | Belgium | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25367412 | Derived | 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. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
First patient enrolled 28 August 2012; Last patient enrolled 3 July 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chronic Kidney Disease (CKD) | Participants with CKD on dialysis and treated with PEGylated (PEG) epoetin beta immediately prior to being switched to darbepoetin alfa. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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). | 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. | 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. | Month -3, -2, -1, 1, 2, 3, 4, 5 and 6 |
| Antony |
| 92160 |
| France |
| Research Site | Aurillac | 15000 | France |
| Research Site | Béziers | 34500 | France |
| Research Site | Blois | 41000 | France |
| Research Site | Boulogne-sur-Mer | 62200 | France |
| Research Site | Cahors | 46000 | France |
| Research Site | Essey-lès-Nancy | 54270 | France |
| Research Site | Grabels | 34790 | France |
| Research Site | La Réunion | 97420 | France |
| Research Site | La Roche-sur-Yon | 85925 | France |
| Research Site | Libourne | 33505 | France |
| Research Site | Lille | 59800 | France |
| Research Site | Metz | 57000 | France |
| Research Site | Paris | 75015 | France |
| Research Site | Paris | 75016 | France |
| Research Site | Poitiers | 86021 | France |
| Research Site | Saint-Denis de La Réunion | 97400 | France |
| Research Site | Saint-Nazaire | 44606 | France |
| Research Site | Saint-Pierre | 97410 | France |
| Research Site | Saint-Priest-en-Jarez | 42270 | France |
| Research Site | Strasbourg | 67000 | France |
| Research Site | Vandœuvre-lès-Nancy | 54504 | France |
| Research Site | Kiel | 24106 | Germany |
| Research Site | Nordhorn | 48527 | Germany |
| Research Site | Athens | 11528 | Greece |
| Research Site | Athens | 15562 | Greece |
| Research Site | Arnhem | 6815 AD | Netherlands |
| Research Site | Ribeira | Galicia | 15993 | Spain |
| Research Site | Santiago de Compostela | Galicia | 15701 | Spain |
| Research Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Research Site | Sion | 1950 | Switzerland |
| Received Darbepoetin Alfa |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Primary Analysis Set included all participants who received at least one dose of darbepoetin alfa who completed 26 weeks post-switch on darbepoetin alfa, did not receive another erythropoiesis stimulating agent during this period and had at least one hemoglobin value per month recorded for a minimum of any 4 months post-switch.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chronic Kidney Disease (CKD) | Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin Concentration at Monthly Intervals | Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period. | Primary analysis set; participants with available data at each time point (indicated by "n"). | Posted | Mean | Standard Deviation | g/dL | Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch) |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | Primary analysis set; participants with available data at each time point (indicated by "n"). | Posted | Geometric Mean | 95% Confidence Interval | μg/week | Month -3, Month -2, Month -1 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Primary analysis set; participants with available data at each time point (as indicated by "n"). | Posted | Geometric Mean | 95% Confidence Interval | μg/week | Month 1, 2, 3, 4, 5 and 6 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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). | Primary analysis set | Posted | Geometric Mean | 95% Confidence Interval | ratio | Week -1 and Week 1 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Primary Analysis Set with available data | Posted | Mean | Standard Deviation | g/dL/4 week | Thre months prior to switch and 6 months after the switch |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Primary analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Month -3, -2, -1, 1, 2, 3, 4, 5 and 6 |
|
|
The observation period for individual participants spanned 14 weeks prior to switching from PEG epoetin beta to darbepoetin alfa to a maximum of 26 weeks post-switch.
Adverse drug reactions in the Full Analysis Set (all eligible enrolled participants who received at least one dose of darbepoetin alfa) are reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-switch Period | From 3 months prior to the switch until the date of the switch to darbepoetin alfa. | 0 | 987 | 0 | 987 | ||
| EG001 | Post-switch Period | From the date of the switch to darbepoetin alfa, until up to 6 months. | 0 | 987 | 1 | 987 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flush | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Month 1 (n=763) |
|
| Month 2 (n=755) |
|
| Month 3 (n=749) |
|
| Month 4 (n=754) |
|
| Month 5 (n=739) |
|
| Month 6 (n=742) |
|
|
|
|
|
|