Phase 3 Study of KHK7580

Phase 3 Study of KHK7580 (A Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.

Inclusion Criteria:

• Personally submitted written voluntary informed consent to participate in the study
• Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
• Mean intact PTH level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment

Exclusion Criteria:

• Treatment with cinacalcet hydrochloride within 2 weeks before screening;
• Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
• Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
• Severe heart disease;
• Severe hepatic dysfunction;
• Uncontrolled hypertension and/or diabetes;
• Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
• Primary hyperparathyroidism;
• Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.