This study will assess the efficacy and safety of intravenous R744 in renal anemia patients on hemodialysis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
179
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 Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL
Time frame: 48 weeks
Slope of regression line of Hb concentration (g/dL/week)
Time frame: 48 weeks
Rate of patients who maintain Hb concentration in the range of baseline* ± 1.0g/dL
Time frame: 48 weeks
Rate of patients who maintain Hb concentration in the range of ≥ 10.0g/dL and < 13.0g/dL
Time frame: 48 weeks
Adverse events
Time frame: 48 weeks
Laboratory measurements
Time frame: 48 weeks
Vital signs, standard 12-lead ECG
Time frame: 48 weeks
Anti-R744 antibody titer
Time frame: 48 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