An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis
Completed
- Conditions
- Anemia, Kidney Disease, Chronic
- Registration Number
- NCT01309295
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Chronic kidney disease, in pre-dialysis or dialysis
- Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics
Exclusion Criteria
- Anemia due to non-renal causes
- Pregnant or lactating women
- Uncontrolled hypertension
- Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines 2 years Maintenance of target Hb range (10-12 g/dL) 2 years Safety: Incidence of adverse events 2 years
- Secondary Outcome Measures
Name Time Method Frequency of visits and laboratory assessments 2 years Effect of compliance to treatment on Hb levels 2 years Dosing pattern in clinical practice, including dose adaptations 2 years Correlation between baseline clinical variables and time on target Hb level 2 years