Overview

A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
0
Participant gender:
All
Summary
This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 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 dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;

- receiving sc epoetin alfa or beta for at least 3 months 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 preceding the run-in phase, or during
the run-in or study treatment period.