A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Participants will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kilogram (mcg/kg), or darbepoetin alfa once weekly, at a starting dose of 0.45 mcg/kg (or once every two weeks, 0.75 mcg/kg). The anticipated time on study treatment is 3-12 months.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

Inclusion Criteria:

• Participants with chronic kidney disease (CKD) stage 3 (creatinine clearance [CrCl]/ glomerular filtration rate [GFR] 30 to 59 milliliter per minutes per 1.73 meter square [mL/min/1.73m^2]) or Stage 4 (CrCl/GFR 15-29 mL/min/1.73m^2) who did not require dialysis. CrCl/GFR was estimated with the Cockcroft-Gault equation or the abbreviated Modification of Diet in Renal Disease (MDRD) equation

• Anemia defined as baseline Hb concentration less than (<) 10.5 gram per deciliter (g/dL)

Exclusion Criteria:

• Previous therapy with any ESA within 12 weeks prior to screening

• Renal allograft in place

• Immunosuppressive therapy in the 12 weeks prior to screening

• Overt gastrointestinal bleeding and red blood cells (RBC) transfusions within 8 weeks before screening