Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents in Hemodialysis Centers in Croatia

Completed

• Conditions: Renal Anemia of Chronic Kidney Disease
• Interventions: Other: No intervention

• Registration Number: NCT02625844
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-09
• Status Verified: 2016-02
• Results First Submitted: 2016-02-04
• Results First Submitted QC: 2016-02-04
• Last Update Submitted: 2016-02-04
• Results First Posted: 2016-03-03
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients

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Exclusion Criteria

• Hypersensitivity to the active substance or to any of the excipients
• Uncontrolled hypertension

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monopegylated Epoetin Beta	No intervention	Health care personnel performing anemia management tasks for patients using monopegylated epoetin beta.
Other Erythropoiesis Stimulating Agents (ESAs)	No intervention	Health care personnel performing anemia management tasks for patients using other ESAs.

Primary Outcome Measures

Name	Time	Method
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)