Phase 2 Study of KHK7580

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Parallel-group, Dose-finding Study of KHK7580 for Secondary Hyperparathyroidism Patients Receiving Hemodialysis

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: Placebo
* Drug: KHK7580 low dose
* Drug: KHK7580 middle dose
* Drug: KHK7580 high dose
* Drug: KRN1493


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Plascebo<br> | Drug: Placebo<br>* Oral administration<br>|
| Experimental: KHK7580 low dose<br> | Drug: KHK7580 low dose<br>* Oral administration<br>|
| Experimental: KHK7580 middle dose<br> | Drug: KHK7580 middle dose<br>* Oral administration<br>|
| Experimental: KHK7580 high dose<br> | Drug: KHK7580 high dose<br>* Oral administration<br>|
| Active Comparator: KRN1493<br> | Drug: KRN1493<br>* Oral administration<br>* Other names: cinacalcet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent changes in intact Parathyroid hormone levels from baseline | Percent changes in intact Parathyroid hormone levels from baseline to end of administration period | Up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus. | Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period. | Up to 3 weeks | 
| Safety | Number and types of adverse events laboratory tests vital signs 12-lead electrocardiogram ophthalmological examination | Up to 3 weeks |