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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment
Investigational site (there may be other sites in this country)
Tokyo, Japan
Rate of patients who achieved serum PTH between 60 pg/mL and 240 pg/mL, inclusive
Assessed by laboratory test value
Time frame: 18 weeks
Rate of patients who achieved ≥ 30% or 50% reduction in serum PTH from baseline, respectively
Assessed by laboratory test value
Time frame: 18 weeks
Measured values and Changes from baseline in serum PTH, Ca, P, and serum Ca x P product
Assessed by laboratory test value
Time frame: 52 weeks
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