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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: VIT-45; Drug: Placebo

• Registration Number: NCT00740246
• Lead Sponsor: American Regent, Inc.

Brief 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

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2006-02
• Study Completion: 2006-05
• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Results First Submitted: 2013-10-21
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Results First Posted: 2025-04-18
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 594

Inclusion Criteria

• Subjects > or = 18 years of age and able to give informed consent
• Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit
• Screening Visit laboratory Hgb indicative of anemia
• Screening Visit ferritin indicative of iron deficiency anemia

Exclusion Criteria

• Known hypersensitivity to VIT-45
• Previously received VIT-45
• Parenteral iron in the 4 weeks prior to screening
• Chronic or serious active infection
• Malignancy history
• Aspartate aminotransferase (AST) or Alanine transaminase( ALT) greater than the upper limit of normal
• Anticipated need for surgery or initiation of dialysis during the study
• Pregnant or sexually active females who are not willing to use an effective form of birth control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VIT-45 on Day 0, then Placebo on Day 7	VIT-45	Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. Day 7: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.
VIT-45 on Day 0, then Placebo on Day 7	Placebo	Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. Day 7: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously.
Placebo on Day 0, then VIT-45 on Day 7	VIT-45	Day 0: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.
Placebo on Day 0, then VIT-45 on Day 7	Placebo	Day 0: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. Day 7: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period	Day 0 to 7	Number of participants with any treatment-emergent adverse events experienced by participants. The 7-day study period for Study Period 1 ended with the initiation of dosing for Study Period 2. The 7-day study period fo Study Period 2 ended with the completion of Day 14 procedures.

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States