NCT00740246

Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 594 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Detailed description

Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	VIT-45	15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously
DRUG	Placebo	for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-02-01
• Completion: 2006-05-01
• First posted: 2008-08-22
• Last updated: 2025-04-18
• Results posted: 2025-04-18

Locations

1 site across 1 country: United States