This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Oral administration
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Tokyo, Japan
Number of participants with adverse events
Adverse Event collection and assessment
Time frame: Up to 52 weeks
Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
Time frame: Up to 52 weeks
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
Time frame: Up to 52 weeks
Mean percent change in intact PTH level from baseline
Time frame: Up to 52 weeks
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