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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01105494
First received: April 14, 2010
Last updated: September 12, 2012
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Anemia
 Drug: epoetin beta [NeoRecormon]
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Evaluating the Quality of Life in Dialysis Patients With End Stage Renal Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Quality of life assessment: Kidney Disease Quality of Life Questionnaire [ Time Frame: Throughout study: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of factors (demographic and social characteristics, dialysis method) influencing the quality of life [ Time Frame: Throughout study: 6 months ] [ Designated as safety issue: No ]

Enrollment: 6000
Study Start Date: December 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: epoetin beta [NeoRecormon]
    As prescribed by physician
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105494

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01105494     History of Changes
Other Study ID Numbers: ML21906
Study First Received: April 14, 2010
Last Updated: September 12, 2012
Health Authority: Morocco: Ministry of Public Health

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Hematologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013