Anemia
Conditions
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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* Current participation in a clinical trial on renal anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6 | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Monthly dose of Mircera | 6 months |
| Safety: Incidence of adverse events | 6 months |
Countries
France
Outcome results
None listed