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Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01309269
First Posted: March 7, 2011
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 months.

Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hemoglobin Levels at Monthly Intervals [ Time Frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 ]
    Hemoglobin levels were measured as grams/deciliter (g/dL).

  • Percentage of Participants Within Pre-defined Range of Hemoglobin Values [ Time Frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 ]
    Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.

  • Average Methoxy Polyethylene Glycol-epoetin Beta Dose [ Time Frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 ]
    Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.


Enrollment: 1083
Study Start Date: September 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic kidney disease patients treated with Mircera for renal anemia
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with chronic kidney disease (CKD), stages IV and V
  • Treatment with Mircera according to label

Exclusion Criteria:

  • Pregnant or breastfeeding women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309269


Locations
Germany
Lüdenscheid, Germany, 58515
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01309269     History of Changes
Other Study ID Numbers: ML22911
First Submitted: March 3, 2011
First Posted: March 7, 2011
Results First Submitted: September 2, 2015
Results First Posted: October 29, 2015
Last Update Posted: November 2, 2016
Last Verified: November 2016