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This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R744 | Drug | 50μg(i.v.)/2 week until Hb concentration reaches to 11.0g/dL or above, then 25~300μg(i.v.)/4 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration ≥ 1.0g/dL | 26 weeks | |
| Regression line of Hb concentration per week | 26 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takanori Baba | Clinical Research Department 2 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku/Shikoku region | Chugoku/Shikoku | Japan | ||||
| Chubu region |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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| Achievement rate of Hb concentration of ≥ 11.0 g/dL |
| 26 weeks |
| Transition of Hb concentration | 26 weeks |
| dose transition of study drug | 26 weeks |
| Variation of QOL | 26 weeks |
| Adverse events | 26 weeks |
| Laboratory measurements | 26 weeks |
| Vital signs, standard 12-lead ECG | 26 weeks |
| Anti-R744 antibody titer | 26 weeks |
| Chūbu |
| Japan |
| Hokkaido/Tohoku region | Hokkaido/Tohoku | Japan |
| Kanto/Koshinetsu region | Kanto/Koshinetsu | Japan |
| Kinki/Hokuriku region | Kinki/Hokuriku | Japan |
| Kyusyu region | Kyusyu | Japan |