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

NCT00740246 | Completed Phase 3 Results

• 1 other identifier: 1VIT05006
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period

  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.

  Day 0 to 7

Study Arms (2)

VIT-45 on Day 0, then Placebo on Day 7

EXPERIMENTAL

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.

Drug: VIT-45; Drug: Placebo

Placebo on Day 0, then VIT-45 on Day 7

EXPERIMENTAL

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.

Drug: VIT-45; Drug: Placebo

Interventions

VIT-45 DRUG

15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously

Also known as: ferric carboxymaltose

Placebo on Day 0, then VIT-45 on Day 7; VIT-45 on Day 0, then Placebo on Day 7

Placebo DRUG

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 on Day 0, then Placebo on Day 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Location

Related Publications (2)

• Seid MH, Valaoras TG, Barish CF, Dinh Q. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.

  RESULT

• Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Management 2007.

  RESULT

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Mark A Falone
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@americanregent.com

610-650-4200

Study Officials

• David Bregman, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2008
• First Posted: August 22, 2008
• Study Start: July 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: May 1, 2006
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)