The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
404
oral administration
oral administration
Research site_29
Changsha, China
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
Time frame: Week 50- Week 52
Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Time frame: Week 50- Week 52
Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Time frame: Week 50- Week 52
Number of subjects achieving a mean percent decrease in intact PTH level of ≧30% (percent change ≦-30%) from baseline in the evaluation period
Time frame: Week 50- Week 52
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧30% (percent change ≦-30%) from baseline in the evaluation period
Time frame: Week 50- Week 52
Intact PTH level
Time frame: Week 50- Week 52
corrected serum Ca level
Time frame: Week 50- Week 52
serum P level
Time frame: Week 50- Week 52
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Research site_34
Dalian, China
Research site_25
Foshan, China
Research site_22
Guangzhou, China
Research site_23
Guangzhou, China
Research site_30
Guangzhou, China
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Hefei, China
Research site_32
Nanjing, China
Research site_33
Nanjing, China
Research site_24
Shanghai, China
...and 24 more locations