To evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
169
Inoue Hospital
Suita, Osaka, Japan
Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration.
Time frame: Week 8
Changes in serum phosphorous levels from baseline values at each time point.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Concentrations of such as Ca × P product levels at each time point.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
Changes of such as Ca × P product levels from baseline values at each time point.
Time frame: Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8.
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