A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).

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

Details

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

Criteria

Inclusion Criteria:

• regular long term hemodialysis with same schedule for greater than or equal to (>=) 12 weeks

• continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months

• significant acute or chronic bleeding

• poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months

• weekly dose of epoetin beta greater than (>) 16000 international units (IU), or weekly dose of darbepoetin alfa >80 micrograms during previous month