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

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ClinicalTrials.gov Identifier: NCT01309269
Recruitment Status : Completed
First Posted : March 7, 2011
Results First Posted : October 29, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease
Anemia

Study Type : Observational
Actual Enrollment : 1083 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine
Study Start Date : September 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Group/Cohort
Cohort



Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



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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

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

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