drugset / Trial / NCT01341782
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-04
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paricalcitol | Other / unclassified | 2 ug | Intravenous |
| Comparator | maxacalcitol | Small molecule | 5 ug | Intravenous |
| Comparator | maxacalcitol | Small molecule | 10 ug | Intravenous |