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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014