Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine
Completed
- Conditions
- Anemia
- Registration Number
- NCT01309269
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1083
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Patients with chronic kidney disease (CKD), stages IV and V
- Treatment with Mircera according to label
Read More
Exclusion Criteria
- Pregnant or breastfeeding women
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hemoglobin Levels at Monthly Intervals 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 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 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.
- Secondary Outcome Measures
Name Time Method