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An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

This study is currently recruiting participants.
Verified December 2012 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01051323
First received: January 15, 2010
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.


Condition Intervention
Anemia
 Drug: methoxy polyethylene glycol-ep [Mircera]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers

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:
  • Hemoglobin levels over time [ Time Frame: up to 39 months (12 months each patient) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • dose over time [ Time Frame: up to 39 months (12 months each patient) ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: methoxy polyethylene glycol-ep [Mircera]
As prescribed by physician

  Eligibility

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

CKD patients treated with Mirecera at different medical centers

Criteria

Inclusion Criteria:

  • adult patients, >/= 18 years of age
  • chronic kidney disease
  • informed consent for data transmission

Exclusion Criteria:

  • serious hematological or infectious disease
  • acute bleeding in the 16 weeks preceding data collection
  • participation in an interventional trial
  • female patients: pregnancy or breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051323

Contacts
Contact: Please reference Study ID Number: ML22714 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Germany
Recruiting
Saarlouis, Germany, 66740
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: NCT01051323     History of Changes
Other Study ID Numbers: ML22714
Study First Received: January 15, 2010
Last Updated: December 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013