Phase 3 Study of KHK7580

Phase 3

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Drug: KHK7580

• Registration Number: NCT02549404
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-15
• Study Start: 2015-09-28
• Primary Completion: 2016-12-06
• Study Completion: 2016-12-28
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-02
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Personally submitted written voluntary informed consent to participate in the study
• Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
• Intact PTH level of > 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening)

Exclusion Criteria

• Change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening;
• Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening;
• Severe heart disease;
• Severe hepatic dysfunction;
• Uncontrolled hypertension and/or diabetes;
• Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening;
• Primary hyperparathyroidism;
• Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KHK7580	KHK7580	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to 52 weeks	Adverse Event collection and assessment

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL	Up to 52 weeks
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline	Up to 52 weeks
Mean percent change in intact PTH level from baseline	Up to 52 weeks

Trial Locations

Locations (1)

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