An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)
Completed
- Conditions
- Anemia
- Registration Number
- NCT01667380
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
- Patients with chronic renal anemia with stage V CKD on dialysis
- No contraindication to ESA treatment
Exclusion Criteria
- Uncontrolled hypertension
- Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dosage/schedule of Mircera treatment in clinical practice approximately 3 years
- Secondary Outcome Measures
Name Time Method Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment approximately 3 years Change in Hb levels from baseline to Month 12