A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

• Status: Completed
• Trial end date: 2009-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Adult participants, >=18 years of age;

• Chronic renal anemia;

• No ESA therapy during previous 3 months.

Exclusion Criteria:

• Transfusion of red blood cells during previous 2 months;

• Poorly controlled hypertension requiring hospitalization in previous 6 months;

• Significant acute or chronic bleeding.