Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine
Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine
1 other identifier
observational
1,083
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2010
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
October 29, 2015
CompletedNovember 2, 2016
November 1, 2016
3.6 years
March 3, 2011
September 2, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Hemoglobin Levels at Monthly Intervals
Hemoglobin levels were measured as grams/deciliter (g/dL).
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
Percentage of Participants Within Pre-defined Range of Hemoglobin Values
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.
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
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.
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
Study Arms (1)
Cohort
Eligibility Criteria
Chronic kidney disease patients treated with Mircera for renal anemia
You may qualify if:
- Adult patients, \>/= 18 years of age
- Patients with chronic kidney disease (CKD), stages IV and V
- Treatment with Mircera according to label
You may not qualify if:
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Lüdenscheid, 58515, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 7, 2011
Study Start
September 1, 2010
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
November 2, 2016
Results First Posted
October 29, 2015
Record last verified: 2016-11