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This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator |
| |
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R744 | Drug | 25μg(s.c.)/2weeks until Hb concentration reaches to 10g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above, then 25~250μg(s.c.)/4week for 24~26weeks in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hb concentration for term of evaluation | 26 weeks | |
| The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL | 26 weeks | |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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| Epoetin beta | Drug | 6000IU(s.c.)/week until Hb concentration reaches to 10.0g/dL or above and the increasing amount of Hb concentration reaches to 1.0g/dL or above,then 3000k~12000IU(s.c.)/2week for 24~26weeks in total. |
|
| Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration of ≥ 1.0g/dL |
| 26 weeks |
| Slope of regression line of Hb concentration per week | 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 |
| Anti-Epoetin beta 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 |