Examination of paricalcitol compared to maxacalcitol in chronic kidney disease patients with secondary hyperparathyroidism under hemodialysis
Phase 2
- Conditions
- Secondary hyperparthyroidism
- Registration Number
- JPRN-jRCT2080220874
- Lead Sponsor
- Abbott Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
CKD patients with iPTH >=300pg/mL, adjusted Ca 8.4<= - <10.2 mg/dL, P <=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 a >=50% reduction in intact parathyroid hormone from baseline to the average of the last 3 weekts<br><br>The incidence rate of hypercalcemia<br><br>The incidence rate of hyperphosphatemia
- Secondary Outcome Measures
Name Time Method The proportion of subjects with intact parathyroid hormone within target range of 60-180 pg/mL, based on the last 3 weeks<br><br>Frequency of intact parathyroid hormone control (>=50% reduction in intact parathyroid hormone from baseline)<br><br>Frequency of intact parathyroid hormone control (target range of 60-180 pg/mL of iPTH)