A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• chronic renal anemia;

• hemoglobin value less than or equal to (<=) 10.5 grams/deciliter (g/dL).

Exclusion Criteria:

• prior ESA therapy during previous 3 months;

• acute or chronic bleeding requiring therapy during previous 2 months;

• transfusion of red blood cells during previous 2 months;

• active malignant disease (except non-melanoma skin cancer).