Clinical trial NCT03822507: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin China Pharmaceutical Co., Ltd.
name: Kyowa Kirin Korea Co., Ltd.
First posted: 2019-01-30
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period
timeFrame: Week 50- Week 52
Secondary outcomes:
measure: Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
timeFrame: Week 50- Week 52
measure: Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period
timeFrame: Week 50- Week 52
measure: Number of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
timeFrame: Week 50- Week 52
measure: Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧３０% (percent change ≦-３０%) from baseline in the evaluation period
timeFrame: Week 50- Week 52
measure: Intact PTH level
timeFrame: Week 50- Week 52
measure: corrected serum Ca level
timeFrame: Week 50- Week 52
measure: serum P level
timeFrame: Week 50- Week 52
Other outcomes:
Locations:
city: Changsha
country: China
facility: Research site_29
city: Dalian
country: China
facility: Research site_34
city: Foshan
country: China
facility: Research site_25
city: Guangzhou
country: China
facility: Research site_22
city: Guangzhou
country: China
facility: Research site_23
city: Guangzhou
country: China
facility: Research site_30
city: Hefei
country: China
facility: Research site_28
city: Nanjing
country: China
facility: Research site_32
city: Nanjing
country: China
facility: Research site_33
city: Shanghai
country: China
facility: Research site_24
city: Shanghai
country: China
facility: Research site_26
city: Shanghai
country: China
facility: Research site_27
city: Wuxi
country: China
facility: Research site_31
city: Hong Kong
country: Hong Kong
facility: Research site_11
city: Anyang
country: Korea, Republic of
facility: Research site_21
city: Daegu
country: Korea, Republic of
facility: Research site_13
city: Daegu
country: Korea, Republic of
facility: Research site_15
city: Goyang
country: Korea, Republic of
facility: Research site_12
city: Incheon
country: Korea, Republic of
facility: Research site_18
city: Seoul
country: Korea, Republic of
facility: Research site_14
city: Seoul
country: Korea, Republic of
facility: Research site_17
city: Seoul
country: Korea, Republic of
facility: Research site_19
city: Seoul
country: Korea, Republic of
facility: Research site_20
city: Ulsan
country: Korea, Republic of
facility: Research site_16
city: Kaohsiung
country: Taiwan
facility: Research site_2
city: Kaohsiung
country: Taiwan
facility: Research site_3
city: Kaohsiung
country: Taiwan
facility: Research site_5
city: Taichung
country: Taiwan
facility: Research site_9
city: Tainan
country: Taiwan
facility: Research site_4
city: Tainan
country: Taiwan
facility: Research site_7
city: Taipei
country: Taiwan
facility: Research site_10
city: Taipei
country: Taiwan
facility: Research site_1
city: Taipei
country: Taiwan
facility: Research site_6
city: Taipei
country: Taiwan
facility: Research site_8
Study officials:
References: