Renal Anemia of Chronic Kidney Disease
Conditions
Brief summary
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.
Interventions
OTHERNo intervention
No intervention administered in this study.
Sponsors
Hoffmann-La Roche
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients
Exclusion criteria
* Hypersensitivity to the active substance or to any of the excipients * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Up to 3 months | Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs) |
Countries
Croatia
Participant flow
Pre-assignment details
Patient disposition information was unavailable. Therefore, all participants are represented in one arm.
Participants by arm
| Arm | Count |
|---|---|
| Erythropoiesis Stimulating Agents (ESAs) Healthcare personnel performing anemia care for patients. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Erythropoiesis Stimulating Agents (ESAs) |
|---|---|
| Age, Customized >/= 18 years | 110 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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)
Time frame: Up to 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Monopegylated Site 1 | 38 hours/year |
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Monopegylated Site 2 | 15 hours/year |
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Monopegylated Site 3 | 17 hours/year |
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Monopegylated Site 4 | 5 hours/year |
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Other ESAs Site 1 | 143 hours/year |
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Other ESAs Site 2 | 39 hours/year |
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Other ESAs Site 3 | 48 hours/year |
| Erythropoiesis Stimulating Agents (ESAs) | Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Other ESAs Site 4 | 22 hours/year |