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