NCT00317226

Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Open Label Extension Study Evaluating the Long Term Safety, Tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing Intravenous VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).

Detailed description

The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004. In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit

Timeline

• Start date: 2005-06-01
• Primary completion: 2007-03-01
• Completion: 2007-09-01
• First posted: 2006-04-24
• Last updated: 2018-02-20
• Results posted: 2015-06-10

Locations

1 site across 1 country: United States