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

Completed · Phase 3 · Has a placebo group

Conditions studied: Anemia

In brief

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

Key facts

Study ID

NCT00740246

Run by

American Regent, Inc.

People needed

594

Starts

2005-07-01

Expected to finish

2006-05-01

Last updated by the study team

2025-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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