NCT01341782

Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Hyperparathyroidism
• Hemodialysis

Interventions

Type	Name	Description
DRUG	paricalcitol
DRUG	maxacalcitol
DRUG	paricalcitol placebo
DRUG	maxacalcitol placebo

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-04-26
• Last updated: 2013-06-06
• Results posted: 2013-06-06

Locations

45 sites across 1 country: Japan