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

NCT01341782

Phase 3 Completed 255 enrolled AbbVie
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

EvaluationDrugModalityDoseRoute
Subject Paricalcitol Other / unclassified 2 ug Intravenous
Comparator maxacalcitol Small molecule 5 ug Intravenous
Comparator maxacalcitol Small molecule 10 ug Intravenous