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NCT01105494 Clinical Trial

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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01105494
Other study ID # ML21906
Secondary ID
Status Completed
Phase Phase 4
First received April 14, 2010
Last updated September 12, 2012
Start date December 2008
Est. completion date June 2012

Study information
Verified date June 2011
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Morocco: Ministry of Public Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6000
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• epoetin beta [NeoRecormon]
As prescribed by physician

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Morocco, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life assessment: Kidney Disease Quality of Life Questionnaire Throughout study: 6 months No
Secondary Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life Throughout study: 6 months No
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