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A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01379963
First received: June 22, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).


Condition
Anemia, Kidney Disease, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta)

Resource links provided by NLM:

MedlinePlus related topics: Anemia
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients achieving a 3-months hemoglobin level stabilization within the range of 11-12 g/dL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving a 6-months hemoglobin level stabilization within the range of 11-12 g/dL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 780
Study Start Date: April 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

  Eligibility

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

Patients with renal anemia on treatment with Mircera

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Renal anemia treated with Mircera for at least 6 months before entering study

Exclusion Criteria:

  • Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379963

Locations
Greece
Arta, Greece, 47100
Athens, Greece, 11521
Athens, Greece, 11528
Athens, Greece, 10433
Athens, Greece, 11362
Athens, Greece, 15562
Daphni-athens, Greece, 17237
Egaleo, Greece, 12244
Patra, Greece, 26443
Patra, Greece, 26225
Pireus, Greece, 42356
Polygyros, Greece, 63100
Thessaloniki, Greece, 57010
Thessaloniki, Greece, 57001
Thessaloniki, Greece, 57500
Volos, Greece, 38222
Volos, Greece, 38221
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: NCT01379963     History of Changes
Other Study ID Numbers: ML22014
Study First Received: June 22, 2011
Last Updated: June 3, 2013
Health Authority: Greece: National Organization for Medicines

Additional relevant MeSH terms:
Anemia
Chronic Disease
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Hematologic Diseases
Disease Attributes
Pathologic Processes
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013