Phase 3 Study of KHK7580

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Secondary Hyperparathyroidism

Treatments

Drug: KHK7580

Study type

Interventional

Funder types

Industry

Identifiers

NCT02549404

7580-011

Details and patient eligibility

About

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.

Enrollment

137 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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
Intact PTH level of > 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)

Exclusion criteria

Change in dose or dosing regimen of cinacalcet hydrochloride or 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.