Phase 3 Study of KHK7580

Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

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.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism
• Intervention / Treatment: Drug: KHK7580

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KHK7580	Drug: KHK7580; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse events	Adverse Event collection and assessment	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 28, 2015
• Primary Completion (Actual): December 6, 2016
• Study Completion (Actual): December 28, 2016

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: July 2, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary
• Other Study ID Numbers: 7580-011