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This study is to document the time spent by health care personnel on anemia-related tasks, including preparation, distribution and administration of monopegylated epoetin beta (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal disease in hemodialysis centers in Croatia. The total average time will be determined for the same number of patients on monopegylated epoetin beta and patients on other ESAs. In addition, qualitative information will be obtained on changes in practice patterns that may have occurred with the introduction of monopegylated epoetin beta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monopegylated Epoetin Beta | Health care personnel performing anemia management tasks for patients using monopegylated epoetin beta. |
| |
| Other Erythropoiesis Stimulating Agents (ESAs) | Health care personnel performing anemia management tasks for patients using other ESAs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs) | Up to 3 months |
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Inclusion Criteria:
- Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients
Exclusion Criteria:
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Health care personnel providing care for patients with renal anemia on monopegylated epoetin beta or other erythropoiesis stimulating agents (ESAs)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bjelovar | 43000 | Croatia | ||||
Patient disposition information was unavailable. Therefore, all participants are represented in one arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erythropoiesis Stimulating Agents (ESAs) | Healthcare personnel performing anemia care for patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erythropoiesis Stimulating Agents (ESAs) | Healthcare personnel performing anemia care for patients. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs) | Posted | Number | hours/year | Up to 3 months |
|
|
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Adverse events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erythropoiesis Stimulating Agents (ESAs) | Healthcare personnel performing anemia care for patients. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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| Split |
| 21000 |
| Croatia |
| Zadar | 23000 | Croatia |
| Zagreb | 10000 | Croatia |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 0 |
| 0 |
| 0 |
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.