Study of KHK7580 in Subjects With Secondary Hyperparathyroidism in Asia
Phase 3
Completed
- Conditions
- Secondary Hyperparathyroidism
- Interventions
- Drug: KHK7580
- Registration Number
- NCT03822507
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cinacalcet 25mg-100mg Cinacalcet Hydrochloride - KHK7580 1mg-12mg KHK7580 -
- Primary Outcome Measures
Name Time Method Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period Week 50- Week 52
- Secondary Outcome Measures
Name Time Method 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 Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period Week 50- Week 52 Intact PTH level Week 50- Week 52 corrected serum Ca level Week 50- Week 52 serum P level 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
Trial Locations
- Locations (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
Scroll for more (24 remaining)Research site_29🇨🇳Changsha, China