Phase 3 Study of SK-1403

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.

Official Title
-----------------
Phase 3 Study of SK-1403 ; Double-blinded Parallel Group in Patients With Secondary Hyperparathyroidism Receiving Hemodialysis

Conditions
-----------------
Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: SK-1403
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum PTH>240 pg/mL at the screening Serum corrected Ca≧8.4 mg/dL at the screening Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration Exclusion Criteria: Primary hyperparathyroidism Severe liver disease Severe Cardiac disease History or family history of long QT syndrome Malignant tumor Uncontrolled diabetes mellitus Uncontrolled hypertension History of severe drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SK-1403<br>Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. | Drug: SK-1403<br>* Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.<br>|
| Placebo Comparator: Placebo<br>Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. | Drug: Placebo<br>* Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week. | Assessed by laboratory test value | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point. | Assessed by laboratory test value | 24 weeks | 
| Measured values and Changes from baseline in serum PTH | Assessed by laboratory test value; unit of measure (pg/mL) | 24 weeks | 
| Measured values and Changes from baseline in Ca | Assessed by laboratory test value; unit of measure (mg/dL) | 24 weeks | 
| Measured values and Changes from baseline in ionized Ca | Assessed by laboratory test value; unit of measure (mEq/dL) | 24 weeks | 
| Measured values and Changes from baseline in P | Assessed by laboratory test value; unit of measure (mg/dL) | 24 weeks | 
| Measured values and Changes from baseline in serum Ca x P product | Assessed by laboratory test value | 24 weeks |