Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: KHK7580

Study type: Interventional

Funder types: Industry

Identifiers

NCT02143271

7580-004

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening
• intact parathyroid hormone 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 who began to take or changed the dose/dosing regimen of active vitamin D/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
• Patients who underwent 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 another clinical trial within 12 weeks prior to the screening
• Patients who have been judged ineligible to participate in the study by the investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

KHK7580

Experimental group

Treatment:

Drug: KHK7580