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

February 4, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Bjelovar, Croatia, 43000
      • Split, Croatia, 21000
      • Zadar, Croatia, 23000
      • Zagreb, Croatia, 10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Health care personnel providing care for patients with renal anemia on monopegylated epoetin beta or other erythropoiesis stimulating agents (ESAs)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Monopegylated Epoetin Beta
Health care personnel performing anemia management tasks for patients using monopegylated epoetin beta.
Other: No intervention
No intervention administered in this study.
Other Erythropoiesis Stimulating Agents (ESAs)
Health care personnel performing anemia management tasks for patients using other ESAs.
Other: No intervention
No intervention administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs)
Time Frame: Up to 3 months
Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs)
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25720

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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