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This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. 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 |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoetin beta | Drug | As prescribed |
| |
| methoxy polyethylene glycol-epoetin beta [Mircera] |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin concentration between baseline and the EEP | Week 20-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP. | Weeks 1-28 | |
| Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP. |
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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 |
|---|---|---|---|---|---|---|
| Beijing | 100034 | China | ||||
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| Drug |
120, 200 or 360 micrograms every 4 weeks |
|
| Weeks 1-28 |
| Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG. | Throughout study |
| Beijing |
| 100044 |
| China |
| Beijing | 100050 | China |
| Beijing | 100083 | China |
| Beijing | 100853 | China |
| Chengdu | 610072 | China |
| Guangzhou | 510515 | China |
| Guangzhou | China |
| Hangzhou | 310003 | China |
| Nanjing | 210009 | China |
| Nanjing | 210036 | China |
| Shanghai | 200001 | China |
| Shanghai | 200025 | China |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
| C508420 | continuous erythropoietin receptor activator |
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