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

Phase 1

Completed

• Conditions: Hyperparathyroidism
• Interventions: Drug: KHK7580

• Registration Number: NCT01935856
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-02
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-05
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KHK7580	KHK7580	-

Primary Outcome Measures

Name	Time	Method
The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination	For 19 weeks	The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination

Secondary Outcome Measures

Name	Time	Method
Profiles of pharmacodynamics	For 4-15 days after every dosing	intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin
Profiles of pharmacokinetics	Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period	Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin; 🇯🇵 Tokyo, Japan