Phase 3 double-blind study of KHK7580
Phase 3
- Conditions
- Secondary hyperparathyroidism receiving hemodialysis
- Registration Number
- JPRN-jRCT2080222961
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 600
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
- Mean intact parathyroid hormone (PTH) level of > 240 pg/ml at screening, at 2 weeks and 1 week before the start of study treatment
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>Number and percentage of subjects in the evaluation period achieving a mean intact PTH level of >= 60 pg/mL and =<240 pg/m
- Secondary Outcome Measures
Name Time Method Efficacy<br>Number and percentage of subjects in the evaluation period achieving a mean percent decrease in intact PTH level of >= 30% (percent change =<-30%) from baseline