Status:
COMPLETED
Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Kirin China Pharmaceutical Co., Ltd.
Kyowa Kirin Korea Co., Ltd.
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2021
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT03822507
Start Date
April 9 2019
End Date
September 23 2021
Last Update
April 25 2022
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Research site_29
Changsha, China
2
Research site_34
Dalian, China
3
Research site_25
Foshan, China
4
Research site_22
Guangzhou, China