Phase 2 Study of KHK7580

A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis

This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.

Inclusion Criteria:

• Subjects who have voluntarily consented to participate in this study
• Subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening
• Subjects with an intact Parathyroid hormone of >= 240 pg/mL at screening

Exclusion Criteria:

• Subjects with primary hyperparathyroidism
• Subjects who have received cinacalcet hydrochloride within 2 weeks before screening
• Subjects whose dose or dosing regimen of an active vitamin D drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening.
• Subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening.
• Subjects with uncontrolled hypertension and/or diabetes
• Subjects with severe heart disease.
• Subjects with severe hepatic dysfunction.
• Subjects who have received any other investigational drug within 12 weeks before screening
• Other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.