Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Phase 1

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: KHK7580

• Registration Number: NCT02143271
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-03
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KHK7580	KHK7580	-

Primary Outcome Measures

Name	Time	Method
Number and types of adverse events	For 8 days	The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram

Secondary Outcome Measures

Name	Time	Method
Profiles of pharmacokinetics	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose	intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin

Trial Locations

Locations (1)

Kyowa Hakko Kirin; 🇯🇵 Tokyo, Japan