Phase 2 Study of KHK7580

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Cinacalcet; Cinacalcet Hydrochloride

Criteria

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.