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Clinical Trials/NCT01105494
NCT01105494
Completed
N/A

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

Hoffmann-La Roche0 sites6,000 target enrollmentDecember 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anemia
Sponsor
Hoffmann-La Roche
Enrollment
6000
Primary Endpoint
Quality of life assessment: Kidney Disease Quality of Life Questionnaire
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
June 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Quality of life assessment: Kidney Disease Quality of Life Questionnaire

Time Frame: Throughout study: 6 months

Secondary Outcomes

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

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