Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
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This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis
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Ages Eligible for Study:
20 Years to 74 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Written informed consent
Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening
intact PTH value ≥ 240 pg/mL at the screening
Corrected serum calcium ≥ 8.4 mg/dL at the screening
Patients with primary hyperparathyroidism
Patients who received cinacalcet within 2 weeks prior to the screening
Patients with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
Patients who received parathyroidectomy and/or parathyroid intervention
Patients with uncontrolled hypertension and/or diabetes
Patients with severe heart disorder
Patients with severe hepatic disease
Patients who take investigational drug in other clinical trial within 12 weeks prior to the screening
Patients who have been judged ineligible to participate in the study by the investigator