This study used as the comparative drug (epoetin beta) will assess the efficacy and safety of subcutaneous R744 in renal anemia patients on Predialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
187
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.
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.
Chugoku/Shikoku region
Chugoku/Shikoku, Japan
Chubu region
Chūbu, Japan
Hokkaido/Tohoku region
Hokkaido/Tohoku, Japan
Kanto/Koshinetsu region
Kanto/Koshinetsu, Japan
Kinki/Hokuriku region
Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL
Time frame: 26 weeks
Mean Hb concentration for term of evaluation
Time frame: 26 weeks
The ratio of patients whose Hb concentration reach ≥ 10.0g/dL and increasing amount of Hb concentration reach ≥ 1.0g/dL
Time frame: 26 weeks
Time required for reaching Hb concentration of ≥ 10.0 g/dL and reaching increasing amount of Hb concentration of ≥ 1.0g/dL
Time frame: 26 weeks
Slope of regression line of Hb concentration per week
Time frame: 26 weeks
Variation of QOL
Time frame: 26 weeks
Adverse events
Time frame: 26 weeks
Laboratory measurements
Time frame: 26 weeks
Vital signs, standard 12-lead ECG
Time frame: 26 weeks
Anti-R744 antibody titer
Time frame: 26 weeks
Anti-Epoetin beta antibody titer
Time frame: 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kinki/Hokuriku, Japan
Kyusyu region
Kyusyu, Japan