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

Completed

• Conditions: Anemia

• Registration Number: NCT01105494
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Status Verified: 2011-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-09-12
• Last Update Posted: 2012-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life assessment: Kidney Disease Quality of Life Questionnaire	Throughout study: 6 months

Secondary Outcome Measures

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