Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

Study Overview
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Brief Summary
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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.

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

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: KHK7580
* Drug: Cinacalcet Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Personally submitted written voluntary informed consent to participate in the study Aged ≧18 years at the time of consent Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening Intact PTH level (centrally measured) of >300 pg/mL at screening Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL 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 Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification) Severe hepatic dysfunction (e.g., treatment with antiviral therapy) Uncontrolled hypertension and/or diabetes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK7580 1mg-12mg<br> | Drug: KHK7580<br>* oral administration<br>|
| Active Comparator: Cinacalcet 25mg-100mg<br> | Drug: Cinacalcet Hydrochloride<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period |  | Week 50- Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period |  | Week 50- Week 52 | 
| Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period |  | Week 50- Week 52 | 
| Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period |  | Week 50- Week 52 | 
| Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period |  | Week 50- Week 52 | 
| Intact PTH level |  | Week 50- Week 52 | 
| corrected serum Ca level |  | Week 50- Week 52 | 
| serum P level |  | Week 50- Week 52 |