A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
Status:
Terminated
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal
dialysis patients who self-inject at home or receive in-centre injections. The safety of
subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be
assessed. Eligible patients will be randomized either to receive monthly sc injections of
Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms,
or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to
reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is
3-12 months, and the target sample size is 380 individuals.