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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

Criteria

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