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Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

Primary Purpose

Secondary Hyperparathyroidism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
KHK7580
Cinacalcet Hydrochloride
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

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

Inclusion Criteria:

  1. Personally submitted written voluntary informed consent to participate in the study
  2. Aged ≧18 years at the time of consent
  3. Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening
  4. Intact PTH level (centrally measured) of >300 pg/mL at screening
  5. Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening

Exclusion Criteria:

  1. Treatment with cinacalcet hydrochloride within 2 weeks before screening
  2. Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening
  3. Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening
  4. Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening
  5. Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening
  6. Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification)
  7. Severe hepatic dysfunction (e.g., treatment with antiviral therapy)
  8. Uncontrolled hypertension and/or diabetes

Sites / Locations

  • Research site_29
  • Research site_34
  • Research site_25
  • Research site_22
  • Research site_23
  • Research site_30
  • Research site_28
  • Research site_32
  • Research site_33
  • Research site_24
  • Research site_26
  • Research site_27
  • Research site_31
  • Research site_11
  • Research site_21
  • Research site_13
  • Research site_15
  • Research site_12
  • Research site_18
  • Research site_14
  • Research site_17
  • Research site_19
  • Research site_20
  • Research site_16
  • Research site_2
  • Research site_3
  • Research site_5
  • Research site_9
  • Research site_4
  • Research site_7
  • Research site_10
  • Research site_1
  • Research site_6
  • Research site_8

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KHK7580 1mg-12mg

Cinacalcet 25mg-100mg

Arm Description

Outcomes

Primary Outcome Measures

Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period

Secondary Outcome Measures

Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Intact PTH level
corrected serum Ca level
serum P level

Full Information

First Posted
January 29, 2019
Last Updated
April 21, 2022
Sponsor
Kyowa Kirin Co., Ltd.
Collaborators
Kyowa Kirin China Pharmaceutical Co., Ltd., Kyowa Kirin Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03822507
Brief Title
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
Official Title
A Phase 3, Randomized, Double-Blind, Intra-Subject Dose-Adjustment, Parallel-Group Study of KHK7580 and Cinacalcet Hydrochloride in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 9, 2019 (Actual)
Primary Completion Date
September 23, 2021 (Actual)
Study Completion Date
September 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
Collaborators
Kyowa Kirin China Pharmaceutical Co., Ltd., Kyowa Kirin Korea Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KHK7580 1mg-12mg
Arm Type
Experimental
Arm Title
Cinacalcet 25mg-100mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
KHK7580
Intervention Description
oral administration
Intervention Type
Drug
Intervention Name(s)
Cinacalcet Hydrochloride
Intervention Description
oral administration
Primary Outcome Measure Information:
Title
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
Time Frame
Week 50- Week 52
Secondary Outcome Measure Information:
Title
Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Time Frame
Week 50- Week 52
Title
Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Time Frame
Week 50- Week 52
Title
Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Time Frame
Week 50- Week 52
Title
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Time Frame
Week 50- Week 52
Title
Intact PTH level
Time Frame
Week 50- Week 52
Title
corrected serum Ca level
Time Frame
Week 50- Week 52
Title
serum P level
Time Frame
Week 50- Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Personally submitted written voluntary informed consent to participate in the study Aged ≧18 years at the time of consent Stable chronic renal failure treated with hemodialysis 3 times weekly for at least 12 weeks before screening Intact PTH level (centrally measured) of >300 pg/mL at screening Corrected serum Ca level (centrally measured) of ≧9.0 mg/dL at screening Exclusion Criteria: Treatment with cinacalcet hydrochloride within 2 weeks before screening Change in dose or dosing regimen of an activated vitamin D drug or its derivative, phosphate binder, or Ca preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening Change in prescribed conditions of dialysis (dialysate Ca concentration, prescribed dialysis time, and prescribed number of dialysis per week) within 2 weeks before screening Treatment with bisphosphonates, denosumab or teriparatide within 24 weeks before screening Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening Severe heart disease (e.g., ≧ Class Ⅲ per New York Heart Association classification) Severe hepatic dysfunction (e.g., treatment with antiviral therapy) Uncontrolled hypertension and/or diabetes
Facility Information:
Facility Name
Research site_29
City
Changsha
Country
China
Facility Name
Research site_34
City
Dalian
Country
China
Facility Name
Research site_25
City
Foshan
Country
China
Facility Name
Research site_22
City
Guangzhou
Country
China
Facility Name
Research site_23
City
Guangzhou
Country
China
Facility Name
Research site_30
City
Guangzhou
Country
China
Facility Name
Research site_28
City
Hefei
Country
China
Facility Name
Research site_32
City
Nanjing
Country
China
Facility Name
Research site_33
City
Nanjing
Country
China
Facility Name
Research site_24
City
Shanghai
Country
China
Facility Name
Research site_26
City
Shanghai
Country
China
Facility Name
Research site_27
City
Shanghai
Country
China
Facility Name
Research site_31
City
Wuxi
Country
China
Facility Name
Research site_11
City
Hong Kong
Country
Hong Kong
Facility Name
Research site_21
City
Anyang
Country
Korea, Republic of
Facility Name
Research site_13
City
Daegu
Country
Korea, Republic of
Facility Name
Research site_15
City
Daegu
Country
Korea, Republic of
Facility Name
Research site_12
City
Goyang
Country
Korea, Republic of
Facility Name
Research site_18
City
Incheon
Country
Korea, Republic of
Facility Name
Research site_14
City
Seoul
Country
Korea, Republic of
Facility Name
Research site_17
City
Seoul
Country
Korea, Republic of
Facility Name
Research site_19
City
Seoul
Country
Korea, Republic of
Facility Name
Research site_20
City
Seoul
Country
Korea, Republic of
Facility Name
Research site_16
City
Ulsan
Country
Korea, Republic of
Facility Name
Research site_2
City
Kaohsiung
Country
Taiwan
Facility Name
Research site_3
City
Kaohsiung
Country
Taiwan
Facility Name
Research site_5
City
Kaohsiung
Country
Taiwan
Facility Name
Research site_9
City
Taichung
Country
Taiwan
Facility Name
Research site_4
City
Tainan
Country
Taiwan
Facility Name
Research site_7
City
Tainan
Country
Taiwan
Facility Name
Research site_10
City
Taipei
Country
Taiwan
Facility Name
Research site_1
City
Taipei
Country
Taiwan
Facility Name
Research site_6
City
Taipei
Country
Taiwan
Facility Name
Research site_8
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia

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