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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01105494
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : September 13, 2012
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment
Anemia Drug: epoetin beta [NeoRecormon]

Study Type : Observational
Actual Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease
Study Start Date : December 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Intervention Details:
    Drug: epoetin beta [NeoRecormon]
    As prescribed by physician

Primary Outcome Measures :
  1. Quality of life assessment: Kidney Disease Quality of Life Questionnaire [ Time Frame: Throughout study: 6 months ]

Secondary Outcome Measures :
  1. Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life [ Time Frame: Throughout study: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dialysis patients with end-stage kidney disease on treatment with epoetin beta [Neorecormon]

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01105494

Casablanca, Morocco, 20000
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01105494     History of Changes
Other Study ID Numbers: ML21906
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: June 2011

Additional relevant MeSH terms:
Hematologic Diseases
Epoetin Alfa