Overview

A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
Summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.
Phase:
Phase 3
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Epoetin Alfa