To evaluate the superiority to placebo, dose-responsibility and safety.
This is a multi-center, randomized, double blind placebo-controlled and open label sevelamer hydrochloride-controlled, dose-ranging study in CKD patients with hyperphosphatemia on hemodialysis. Patients will be randomly allocated to one of the five treatment groups (ASP1585: 3 dose, placebo, Sevelamer hydrochloride) and advance to the 4-week treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
156
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kyushu, Japan
Change in serum phosphorus
Time frame: 4 weeks
Change in serum phosphorus level by time
Time frame: Up to 4 weeks
Percent of patients meeting the target range of serum phosphorus (3.5-6.0 mg/dL) and achieving time
Time frame: 4 Weeks
Change in corrected serum Ca level
Time frame: 4 weeks
Change in Ca×P
Time frame: 4 weeks
Change in intact PTH
Time frame: 4 weeks
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Unnamed facility
Shikoku, Japan