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Phase 3 Study of KHK7580

Primary Purpose

Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK7580
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KHK7580

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events
Adverse Event collection and assessment

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2015
Last Updated
July 2, 2017
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02549404
Brief Title
Phase 3 Study of KHK7580
Official Title
Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 28, 2015 (undefined)
Primary Completion Date
December 6, 2016 (Actual)
Study Completion Date
December 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK7580
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK7580
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Description
Adverse Event collection and assessment
Time Frame
Up to 52 weeks
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL
Time Frame
Up to 52 weeks
Title
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline
Time Frame
Up to 52 weeks
Title
Mean percent change in intact PTH level from baseline
Time Frame
Up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
City
Tokyo
Country
Japan

12. IPD Sharing Statement

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Phase 3 Study of KHK7580

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