An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)
Completed
- Conditions
- Anemia
- Registration Number
- NCT01974271
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 661
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Chronic kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months
- Previously treated with an erythropoietin stimulating agent (ESA)
- Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
- Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL
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Exclusion Criteria
- Current participation in a clinical trial on renal anemia
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6 6 months
- Secondary Outcome Measures
Name Time Method Monthly dose of Mircera 6 months Percentage of patients with Hb value within the range of 10 - 12 g/dL 6 months Change in Hb level from baseline to Month 6 Safety: Incidence of adverse events 6 months