For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548. For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
Oral tablet
Subcutaneous
Research site
Aichi, Japan
Research site
Mean Hb Level of Week 20 and Week 24
Time frame: Up to Week 24
Mean Hb Level of Week 48 and Week 52
Time frame: Up to Week 52
Hb Level at Each Assessment Time Point
Time frame: Up to Week 52
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Time frame: Up to Week 52
Time to Reach the Target Hb Range in Correction Group Only
Time frame: Up to Week 52
Rate of Increase in Hb Level in Correction Group Only
Time frame: Up to Week 6
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Chiba, Japan
Research site
Fukui, Japan
Research site
Fukuoka, Japan
Research site
Fukushima, Japan
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Gunma, Japan
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Hiroshima, Japan
Research site
Hokkaido, Japan
Research site
Hyōgo, Japan
Research site
Ibaraki, Japan
...and 21 more locations