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

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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