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Completed

NCT Number: NCT00740246

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

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

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIT-45

Drug

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

Other names: ferric carboxymaltose

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

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 22, 2008
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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