Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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