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This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). 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, 3 times weekly |
| |
| methoxy polyethylene glycol-epoetin beta [Mircera] |
| Measure | Description | Time Frame |
|---|---|---|
| Hb response rate | Weeks 0-24 | |
| Change in Hb concentration between baseline and evaluation period | Months 4-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Hb over time | Throughout study | |
| Time to Hb response | Throughout study | |
| RBC transfusions |
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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 | 100050 | China | ||||
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| Drug |
0.4 micrograms/kg iv every 2 weeks |
|
| Weeks 0-24 |
| AEs, laboratory parameters, vital signs | Throughout study |
| Serum concentration of Mircera | Throughout study |
| Beijing |
| 10029 |
| China |
| Beijing | 100853 | China |
| Chengdu | 610072 | China |
| Guangzhou | 510515 | China |
| Guangzhou | China |
| Hangzhou | 310003 | China |
| Nanjing | 210009 | China |
| Shanghai | 200001 | China |
| Shanghai | 200003 | China |
| Shanghai | 200025 | China |
| Shanghai | 200032 | China |
| Shanghai | 200040 | China |
| Hong Kong | Hong Kong |
| 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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