An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice
Completed
- Conditions
- Anemia
- Registration Number
- NCT01690455
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
Inclusion Criteria
- Adult patients, >/=18 years of age
- Adequate iron status
- Signed informed consent form
Exclusion Criteria
- Anemia due to non-renal causes
- Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
- Pregnant or lactating female patients
- Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who achieve a hemoglobin level of >/=10 g/dl 12 months
- Secondary Outcome Measures
Name Time Method Safety: incidence of adverse events 12 months