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This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of intravenous injections of R744 in renal anemia patients on Hemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
| |
| 4 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R744 | Drug | 100μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of Hb concentration from baseline Hb concentration in evaluation period | week 17~24 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL and maintain Hb concentration in the range of ≥ 9.0g/dL and ≤ 12.0g/dL in evaluation period | week 17~24 | |
| Rate of patients who maintain Hb concentration within ±1.0g/dL of reference Hb |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takanori Baba | Chugai Pharmaceutical,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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| R744 | Drug | 150μg/4week for 8 weeks, then 50~250μg/4week for 16 weeks |
|
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| rHuEPO | Drug | 2250IU or 3000IU(i.v.) 2 or 3 times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks |
|
| rHuEPO | Drug | 4500IU or 6000IU(i.v.) 2 or 3times/week for 8 weeks, then 750~9000IU(i.v.)/1~3week for 16 weeks |
|
| R744 placebo | Drug | 0 μg/4week for 24 weeks |
|
| rHuEPO placebo | Drug | 0 IU 2 or 3 times/week for 8 weeks, then 1~3 times/week for 16 weeks |
|
| week 17~24 |
| Adverse events | throughout study |
| Laboratory measurements | throughout study |
| Vital signs, standard 12-lead ECG | throughout study |
| Anti-R744 antibody titer | throughout study |
| Anti-Epoetin beta antibody titer | throughout study |
| Chūbu |
| Japan |
| Kanto/Koshinetsu region | Kanto/Koshinetsu | Japan |
| Kinki/Hokuriku region | Kinki/Hokuriku | Japan |
| Kyusyu region | Kyusyu | Japan |