Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
NCT ID: NCT03822507
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
404 participants
INTERVENTIONAL
2019-04-09
2021-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KHK7580 1mg-12mg
KHK7580
oral administration
Cinacalcet 25mg-100mg
Cinacalcet Hydrochloride
oral administration
Interventions
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KHK7580
oral administration
Cinacalcet Hydrochloride
oral administration
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Kyowa Kirin China Pharmaceutical Co., Ltd.
INDUSTRY
Kyowa Kirin Korea Co., Ltd.
INDUSTRY
Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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 City, , Taiwan
Research site_7
Tainan City, , Taiwan
Research site_10
Taipei, , Taiwan
Research site_1
Taipei, , Taiwan
Research site_6
Taipei, , Taiwan
Research site_8
Taipei, , Taiwan
Countries
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Other Identifiers
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7580-201
Identifier Type: -
Identifier Source: org_study_id
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