Phase 3 long-term study of KHK7580
Phase 3
- Conditions
- Secondary hyperparathyroidism receiving hemodialysis
- Registration Number
- JPRN-jRCT2080222963
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Personally submitted written voluntary informed consent to participate in the study
- Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening
- Intact parathyroid hormone (PTH) level of > 240 pg/ml at screening (except subjects receiving cinacalcet hydrochroride at screening)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>Adverse Event
- Secondary Outcome Measures
Name Time Method Efficacy<br>Number and percentage of subjects achieving intact PTH level of >= 60 pg/mL and =< 240 pg/m