Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism

Dose Adjustment Trial of SK-1403 in Hemodialysis Patients With Secondary Hyperparathyroidism

This study is conducted to assess the efficacy and safety of SK-1403 in Hemodialysis Patients with Secondary Hyperparathyroidism. In the first treatment period, the efficacy of SK-1403 is assessed after 18 weeks of treatment with SK-1403 individually dose-adjusted . Safety is also assessed during this period. Patients who completed the first treatment period proceed to the second treatment period and receive the treatment with SK-1403 for 34 weeks. Efficacy and safety of SK-1403 are also assessed during this period.

Inclusion Criteria:

• Average serum PTH>240 pg/mL during 2 weeks 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
• A history of severe drug allergy