Phase 3 Study of KHK7580

• Status: Completed
• Trial end date: 2016-12-22
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate efficacy and safety of KHK7580 orally administered once daily for 32 weeks for patients with secondary hyperparathyroidism receiving peritoneal dialysis. After 32-week treatment period, the subjects will receive KHK7580 in the 20-week extension period to evaluate long-term safety and efficacy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Co., Ltd; Kyowa Kirin Co., Ltd.

Criteria

Inclusion Criteria:

• Personally submitted written voluntary informed consent to participate in the study

• Stable chronic renal disease treated with peritoneal dialysis for at least 16 weeks before screening

• Intact PTH level of > 240 pg/ml at screening

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.