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

Renal Anemia of Chronic Kidney Disease Clinical Trial

Official title:

Croatian Time and Motion Survey for Anaemia Management With Erythropoietin Stimulating Agents in Haemodialysis Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625844
• Other study ID #: ML25720
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: February 4, 2016
• Start date: September 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Anemia of Chronic Kidney Disease
• Renal Insufficiency, Chronic

Intervention

Other:
• No intervention
No intervention administered in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	Up to 3 months	No