Comparison of efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism
Phase 3
- Conditions
- Secondary hyperparathyroidism
- Registration Number
- JPRN-jRCT2080221462
- Lead Sponsor
- Abbott Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 252
Inclusion Criteria
Adult Chronic Kidney Disease (CKD) Stage 5 patient with
-intact parathyroid hormone (iPTH) greater than or equal to 300pg/mL
-adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 - less then 10.2 mg/dL
-serum phosphorus (P) less than or equal to 6.5 mg/d
Exclusion Criteria
Patients taking drugs that affect iPTH, calcium or bone metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects with intact parathyroid hormone (iPTH) in the target range of 60-180 pg/mL, based on the average of the last 3 weeks without hypercalcemia during treatment phase
- Secondary Outcome Measures
Name Time Method The proportion of subjects with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks without hypercalcemia during treatment phase <br><br>The proportion of subjects with intact parathyroid hormone (iPTH) in the target range of 60-180 pg/mL based on the average of the last 3 weeks <br><br>The proportion of subjects with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks