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The study was cancelled before any patients were enrolled, due to operational reasons.
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This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy polyethylene glycol-epoetin beta | Drug | 120, 200 or 360 micrograms / 4 weeks iv (starting dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients maintaining average Hb concentration within target range during evaluation period | Weeks 17-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range | Weeks 17-24 | |
| Dose adjustments; RBC transfusions | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg | 9100 | Denmark | ||||
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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| AEs, laboratory parameters, vital signs | Throughout study |
| Fredericia |
| 7000 |
| Denmark |
| Roskilde | 4000 | Denmark |