Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
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
1 other identifier
interventional
404
4 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2019
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
April 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2021
CompletedApril 25, 2022
April 1, 2022
2.5 years
January 29, 2019
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
Week 50- Week 52
Secondary Outcomes (7)
Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Week 50- Week 52
Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
Week 50- Week 52
Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Week 50- Week 52
Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
Week 50- Week 52
Intact PTH level
Week 50- Week 52
- +2 more secondary outcomes
Study Arms (2)
KHK7580 1mg-12mg
EXPERIMENTALCinacalcet 25mg-100mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kyowa Kirin Co., Ltd.lead
- Kyowa Kirin China Pharmaceutical Co., Ltd.collaborator
- Kyowa Kirin Korea Co., Ltd.collaborator
Study Sites (34)
Research site_29
Changsha, China
Research site_34
Dalian, China
Research site_25
Foshan, China
Research site_22
Guangzhou, China
Research site_23
Guangzhou, China
Research site_30
Guangzhou, China
Research site_28
Hefei, China
Research site_32
Nanjing, China
Research site_33
Nanjing, China
Research site_24
Shanghai, China
Research site_26
Shanghai, China
Research site_27
Shanghai, China
Research site_31
Wuxi, China
Research site_11
Hong Kong, Hong Kong
Research site_21
Anyang, South Korea
Research site_13
Daegu, South Korea
Research site_15
Daegu, South Korea
Research site_12
Goyang, South Korea
Research site_18
Incheon, South Korea
Research site_14
Seoul, South Korea
Research site_17
Seoul, South Korea
Research site_19
Seoul, South Korea
Research site_20
Seoul, South Korea
Research site_16
Ulsan, South Korea
Research site_2
Kaohsiung City, Taiwan
Research site_3
Kaohsiung City, Taiwan
Research site_5
Kaohsiung City, Taiwan
Research site_9
Taichung, Taiwan
Research site_4
Tainan, Taiwan
Research site_7
Tainan, Taiwan
Research site_10
Taipei, Taiwan
Research site_1
Taipei, Taiwan
Research site_6
Taipei, Taiwan
Research site_8
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2019
First Posted
January 30, 2019
Study Start
April 9, 2019
Primary Completion
September 23, 2021
Study Completion
September 23, 2021
Last Updated
April 25, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share