To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
213
oral administration
Medical Corporation Seijinkai Ikeda Hospital
Kanoya, Kagoshima-ken, Japan
Incidence rates of all adverse events and adverse drug reactions that occurred or worsened after the initiation of KHK7791 treatment for 52 weeks.
To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.
Time frame: Dose period Week 1~52
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline in the last 3 weeks of the final assessment.
To investigate the efficacy of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in hyperphosphatemic subjects undergoing hemodialysis. Important secondary endpoint
Time frame: Week 1~52
Total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time frame: Week 1~52
Achievement of at least 30% change of the total number of daily prescription tablets of phosphorus binders and KHK7791 from baseline, at each time point after the start of treatment.
Time frame: Week 1~52
The change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time frame: Week 1~52
The rate of change of total daily prescription of phosphate binders and KHK7791 tablets, such as tablet counts, at each time point after the start of treatment.
Time frame: Week 1~52
Concentration of serum phosphorous levels values at each time point.
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Time frame: Week 1~52
Change of serum phosphorous levels from baseline values at each time point.
Time frame: Week 1~52
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0).
Time frame: Week 1~52
Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved.
Time frame: Week 1~52
Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5).
Time frame: Week 1~52
Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved.
Time frame: Week 1~52
Concentrations of such as Ca × P product levels at each time point.
Time frame: Week 1~52
Changes of such as Ca × P product levels from baseline values at each time point.
Time frame: Week 1~52