An Observational Study of Epoetin Beta [Neorecormon] to Evaluate the Quality of Life in Patients on Dialysis With Chronic Renal Anemia

September 12, 2012 updated by: Hoffmann-La Roche

Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease

This multicenter, prospective, observational study will evaluate the quality of life and the factors that influence the quality of life of epoetin beta [Neorecormon] in patients with renal chronic anemia, who are on dialysis. For each eligible patient data will be collected for 6 months. Target sample size is 5000-7000 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6000

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

  • Morocco
      • Casablanca, Morocco, 20000

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

Dialysis patients with end-stage kidney disease on treatment with epoetin beta [Neorecormon]

Description

Inclusion Criteria:

  • Adult patients >/=18 years of age
  • Dialysis patients with chronic renal anemia
  • Written informed consent

Exclusion Criteria:

  • Red blood cell transfusion in the previous 2 months
  • Severe neuropsychological disorder
  • Diabetic patients with serious complications

This trial is being conducted in Morocco.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life assessment: Kidney Disease Quality of Life Questionnaire
Time Frame: Throughout study: 6 months
Throughout study: 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life
Time Frame: Throughout study: 6 months
Throughout study: 6 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

December 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (Estimate)

April 16, 2010

Study Record Updates

Last Update Posted (Estimate)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 12, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21906

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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