A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | June 2004 |
| End Date: | March 2006 |
A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease
This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc)
Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in
chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin.
The anticipated time on study treatment is 3-12 months and the target sample size is 100-500
individuals.
Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in
chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin.
The anticipated time on study treatment is 3-12 months 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 or sc 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
27
sites
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