Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the efficacy and safety of subcutaneous or intravenous R744 in renal anemia patients on Predialysis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R744 | Drug | 100μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Maintenance of target Hb concentration | 24th and 48th week |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of regression line of Hb concentration (g/dL/week) | 24th week | |
| Rate of patients who maintain Hb concentration in the range of baseline ± 1.0g/dL | 24th week | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| R744 | Drug | 150μg(s.c./i.v.)/4 week for 8 weeks, then 25~400μg(s.c./i.v.)/4 week for 40 weeks |
|
|
| Ratio of Maintenance of Hb concentration |
| 24th and 48th week |
| Adverse events | 24th and 48th week |
| Laboratory measurements | 24th and 48th week |
| Vital signs, standard 12-lead ECG | 24th and 48th week |
| Anti-R744 antibody titer | 24th and 48th week |
| Chūbu |
| Japan |
| Hokkaido/Tohoku region | Hokkaido/Tohoku | Japan |
| Kanto/Koshinetsu region | Kanto/Koshinetsu | Japan |
| Kinki/Hokuriku region | Kinki/Hokuriku | Japan |
| Kyusyu region | Kyusyu | Japan |