A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2004 |
| End Date: | August 2005 |
A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance
treatment for renal anemia in chronic kidney disease patients on dialysis who were
previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and
the target sample size is 100-500 individuals.
treatment for renal anemia in chronic kidney disease patients on dialysis who were
previously receiving iv epoetin. The anticipated time on study treatment is 1-2 years and
the target sample size is 100-500 individuals.
Inclusion Criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving IV epoetin for at least 8 weeks before screening.
Exclusion Criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or
during the study period.
We found this trial at
55
sites
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St. John's, Newfoundland and Labrador
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