To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
153
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.
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.
Investigational site (there may be other sites in this country)
Tokyo, Japan
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
Time frame: 24 weeks
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
Time frame: 24 weeks
Measured values and Changes from baseline in serum PTH
Assessed by laboratory test value; unit of measure (pg/mL)
Time frame: 24 weeks
Measured values and Changes from baseline in Ca
Assessed by laboratory test value; unit of measure (mg/dL)
Time frame: 24 weeks
Measured values and Changes from baseline in ionized Ca
Assessed by laboratory test value; unit of measure (mEq/dL)
Time frame: 24 weeks
Measured values and Changes from baseline in P
Assessed by laboratory test value; unit of measure (mg/dL)
Time frame: 24 weeks
Measured values and Changes from baseline in serum Ca x P product
Assessed by laboratory test value
Time frame: 24 weeks
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