An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Adult patients, 18 to 65 years of age, inclusive

• Patients with stage III-IV chronic kidney disease not on dialysis

• Erythropoiesis stimulating agent (ESA) naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL

• Adequate iron status as judged by the treating physician

Exclusion Criteria:

• Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

• Clinically significant concomitant disease or disorder as defined by protocol

• Clinical suspicion of pure red cell aplasia (PRCA)

• Planned elective surgery during the study period , except for cataract surgery or vascular access surgery

• Transfusion of red blood cells in the previous 2 months

• Pregnant women

• Contraindications for Mircera according to local prescribing information or as judged by the investigator