NCT00317239

VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Detailed description

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Ferrous Sulfate tablets	325 mg/TID x 8 weeks
DRUG	Ferric Carboxymaltose (FCM)	A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-02-01
• Completion: 2007-08-01
• First posted: 2006-04-24
• Last updated: 2018-02-20
• Results posted: 2013-11-25

Locations

1 site across 1 country: United States