To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis
This study is a multicenter, double-blind, randomized, Cinacalcet hydrochloride-controlled, parallel-group, dose-ascending study. Subjects judged to be eligible will be registered and randomized into either ASP7991 group (receiving ASP7991 and cinacalcet-placebo) or Cinacalcet group (receiving cinacalcet and ASP7991-placebo), and will receive 12-week (84 days) administration of study drug from first dialysis day in a week (treatment period), in a double-blind manner. The dose of the study drugs will be increased every 3 weeks in dose-ascending manner. Follow-up assessment will be performed before starting first dialysis in a week, 1 week (7 days) after the completion of the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kyushu, Japan
Unnamed facility
Shikoku, Japan
Serum iPTH concentration
iPTH: intact parathyroid hormone
Time frame: Before and at 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment
Corrected serum Ca, Phosphate(P) concentration
Ca x P will be calculated
Time frame: Before and at 3, 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment
serum vitamin D concentration
Time frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment
serum wPTH concentration
wPTH: whole parathyroid hormone
Time frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment
Serum concentration of bone metabolism markers
Bone metabolism markers will be BAP (Bone specific alkaline phosphatase) and TRACP5b (Tartrate-resistant acid phosphatase-5b)
Time frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment
Serum FGF23 concentration
Time frame: Before and at 22, 43, 64, 85 and 92 days after start of the treatment
Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs
Time frame: For 12 weeks after start of treatment
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Unnamed facility
Tōhoku, Japan