Phase 3 Study of KHK7580

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of KHK7580 orally administered once daily for 30 weeks in subjects with secondary hyperparathyroidism (SHPT) receiving hemodialysis in a randomized, double-blind, intra-subject dose-adjustment, parallel-group design with cinacalcet hydrochloride as an active control.

Official Title
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Phase 3 Study of KHK7580 (A 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: KRN1493


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 Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening Mean intact PTH level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment 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.

Ages Eligible for Study
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Minimum Age: 20 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<br> | Drug: KHK7580<br>* Oral administration<br>|
| Active Comparator: KRN1493<br> | Drug: KRN1493<br>* Oral administration<br>* Other names: cinacalcet hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in the evaluation period achieving a mean intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL |  | Weeks 28-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline |  | Weeks 28-30 | 
| Mean percent change in the evaluation period in intact PTH level from baseline |  | Weeks 28-30 |