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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 |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R744 | Drug | 100μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of regression line of Hb concentration (g/dL/week) | 48 weeks | |
| Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL | 48 weeks | |
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Inclusion Criteria:
Patients who have been receiving hemodialysis 3 times a week for at least 12 weeks before registration
Patients aged ≥ 20 years at the time of obtaining consent Patients who have been receiving a rHuEPO preparation at least once a week for at least 8 weeks before registration
Patients whose mean value of Hb concentrations determined before the first dialysis of each week within 8 weeks prior to the registration has been between ≥ 10.0 g/dL and <12.0 g/dL
Patients whose transferrin saturation has been ≥ 20 % or ferritin has been
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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| R744 |
| Drug |
150μg/4 weeks for 8 weeks,then 25~400μg/4 weeks for 40 weeks |
|
| Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL |
| 48 weeks |
| Adverse events | 48 weeks |
| Laboratory measurements | 48 weeks |
| Vital signs, standard 12-lead ECG | 48 weeks |
| Anti-R744 antibody titer | 48 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 |