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This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. 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 [Mircera] | Drug | sc every month (starting dose 1.2 micrograms/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). | Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achievement of response | Throughout study | |
| Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL | Throughout study | |
| Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL |
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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 |
|---|---|---|---|---|---|---|
| Buenos Aires | CP2700 | Argentina | ||||
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| Throughout study |
| Mean time spent in Hb range of 10.0 - 12.0g/dL | Throughout study |
| Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy. | Throughout study |
| La Plata |
| 1900 |
| Argentina |
| San Miguel de Tucumán | 4000 | Argentina |
| Blumenau | 89010-500 | Brazil |
| Botucatu | 18618-000 | Brazil |
| Curitiba | 80250-070 | Brazil |
| Rio de Janeiro | 20551-030 | Brazil |
| São Paulo | 01246-903 | Brazil |
| São Paulo | 04039-901 | Brazil |
| Santiago | 056 | Chile |
| Santiago | 8900000 | Chile |
| Barranquilla | 575 | Colombia |
| Cali | 572 | Colombia |
| Envigado | 571 | Colombia |
| Medellín | 0 | Colombia |
| San José | Costa Rica |
| Quito | 2569 | Ecuador |
| Guatemala City | Guatemala |
| Panama City | Panama |
| Lima | L13 | Peru |
| San Isidro | Lima 27 | Peru |
| Caracas | 1020 | Venezuela |
| 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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