NCT01071070

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

A Phase 3b, Randomized, Active-Controlled, Single-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Injection in Reducing Serum Intact Parathyroid Hormone Levels in Chronic Kidney Disease Stage 5 Subjects Receiving Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Detailed description

Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	paricalcitol	Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-02-19
• Last updated: 2012-01-26
• Results posted: 2012-01-26

Locations

12 sites across 1 country: China