a study to evaluate the effect of asp7991 in secondary hyperparathyroidism patients undergoing hemodialysis

Conditions: Secondary Hyperparathyroidism

Summary: 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.

Eligibility criteria:
inclusion criteria: * patients who are on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week since before 12-week (84 days) administration and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period * patients with secondary hyperparathyroidism * patients whose serum ipth concentration is \>240 pg/ml and corrected serum ca is ≥ 9.0 mg/dl * patients who have had no changes in the following items ≥4-week (28 days). * dosage and regimen, including new administration, of active vitamin d, calcitonin preparation, phosphate binder, and medication with phosphate absorption (including foods) * ca concentration of the dialysate, membrane area of the dialyzer, and dialysis time of each week exclusion criteria: * patients who underwent parathyroid intervention, such as parathyroidectomy (ptx) or percutaneous ethanol injection therapy (peit), within 24 weeks (168 days) prior to the administration * patients who have primary hyperparathyroidism * patients who received bisphosphonate, estrogen preparation, parathyroid hormone within 4 weeks (28 days) * patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmhg and diastolic blood pressure ≥ 120 mmhg are observed at \>2/3 of all confirmable measurements * patients who are complicated by severe heart disorder \[congestive cardiac failure (nyha classification iii or higher), or wide range of old myocardial infarction\], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks (84 days) before administration of the study drug * patients with hepatic function abnormal (alt or ast is \>2× uln, or total bilirubin (t-bil) is \> 1.5 × uln.) * patients with a history of malignant tumor or the patient's condition is complicated by malignant tumor. (however, enrollment is acceptable if the tumor has not relapsed for 5 years or longer.) * patients with a history of serious drug allergy including anaphylactic shock * patients with a history of drug allergy to cinacalcet hydrochloride * female patients who are potentially child-bearing or lactating, or patients who do not comply with the instructed contraceptive measures * patients who were or are currently involved in trials for other investigational drugs or medical devices, or clinical trial for post-marketing study drugs within 12 weeks (84 days) before the study * patients who have received asp7991 in the past * patients who were judged ineligible to participate in the study by the investigator / subinvestigator

Keywords: mineral bone disease(mbd) chronic kidney disease(ckd) secondary hyperparathyroidism(shpt)