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

Kyowa Kirin

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hyperparathyroidism

Treatments

Drug: KHK7580

Study type

Interventional

Funder types

Industry

Identifiers

NCT01935856

7580-003

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

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