An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease on Dialysis (HORTENSIA)
Completed
- Conditions
- Anemia
- Registration Number
- NCT01213485
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Chronic kidney disease, on dialysis for > 3 months
- Treatment-naïve or previous treatment with ESA
- Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician
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Exclusion Criteria
- Participation in a clinical trial
- Anemia due to an associated malignant pathology
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice Month 6 Haemoglobin levels Month 6
- Secondary Outcome Measures
Name Time Method Change in haemoglobin/haematocrit from baseline to Month 12 Biological parameters of anemia: transferrin saturation, serum ferritin, folates 12 months Efficacy of dialysis (Kt/V, urea levels) 12 months Safety: Incidence of adverse events 12 months Compliance (treatment modification or discontinuation) 12 months Quality of life: Short Form (SF-36) questionnaire 12 months