A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
Status:
Terminated
Trial end date:
2008-02-01
Target enrollment:
Participant gender:
Summary
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta
(Mircera) in the maintenance of hemoglobin levels in patients who have previously received
treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic
kidney disease stage 4 through dialysis. Patients will be randomized either to receive
Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc)
Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or
darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation
of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a
starting dose based on their previous (sc) dose, and those in the control group will receive
weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the
target sample size is 500+ individuals.