Overview

A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- adult patients >=18 years of age;

- chronic renal anemia;

- on hemodialysis therapy for at least 3 months;

- receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Exclusion Criteria:

- women who are pregnant, breastfeeding or using unreliable birth control methods;

- use of any investigational drug within 30 days of the run-in phase, or during the
run-in or study treatment period.