Phase 3 Study of SK-1403
Phase 3
Completed
- Conditions
- Secondary Hyperparathyroidism Receiving Hemodialysis
- Registration Number
- JPRN-jRCT2080224528
- Lead Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Serum PTH>240 pg/mL at the screening
-Serum corrected Ca>=8.4 mg/dL at the screening
-Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration
Exclusion Criteria
-Primary hyperparathyroidism
-Severe liver disease
-Severe Cardiac disease
-History or family history of long QT syndrome
-Malignant tumor
-Uncontrolled diabetes mellitus
-Uncontrolled hypertension
-History of severe drug allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Rate of participants who achieved a mean serum iPTH level of >= 60 pg/mL and =< 240 pg/mL from 22 to 24 week.
- Secondary Outcome Measures
Name Time Method efficacy<br>-Rate of participants who achieved a serum iPTH level of >= 60 pg/mL and =< 240 pg/mL at each time point.<br>-Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, serum Ca x P product