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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01051323
First received: January 15, 2010
Last updated: July 7, 2014
Last verified: July 2014

January 15, 2010
July 7, 2014
March 2010
December 2012   (final data collection date for primary outcome measure)
Hemoglobin levels over time [ Time Frame: up to 39 months (12 months each patient) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01051323 on ClinicalTrials.gov Archive Site
dose over time [ Time Frame: up to 39 months (12 months each patient) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

CKD patients treated with Mirecera at different medical centers

Anemia
Drug: methoxy polyethylene glycol-ep [Mircera]
As prescribed by physician
1
Intervention: Drug: methoxy polyethylene glycol-ep [Mircera]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1563
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01051323
ML22714
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP