NCT00701805

Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).

Detailed description

The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).

Conditions

• Secondary Hyperparathyroidism
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Paricalcitol	Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-06-19
• Last updated: 2011-04-19
• Results posted: 2011-04-19

Locations

12 sites across 1 country: Japan