Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

Kyowa Kirin

Status and phase: Completed; Phase 3

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: KHK7580; Drug: Cinacalcet Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT03822507

7580-201

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

Enrollment: 404 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Personally submitted written voluntary informed consent to participate in the study
2. Aged ≧18 years at the time of consent
3. Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
4. Intact PTH level (centrally measured) of >300 pg/mL at screening
5. Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening

Exclusion criteria

1. Treatment with cinacalcet hydrochloride within 2 weeks before screening
2. Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
3. Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
4. Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
5. Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
6. Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
7. Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
8. Uncontrolled hypertension and/or diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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404 participants in 2 patient groups

KHK7580 1mg-12mg

Experimental group

Treatment:

Drug: KHK7580

Cinacalcet 25mg-100mg

Active Comparator group

Treatment:

Drug: Cinacalcet Hydrochloride