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

Anemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740246
• Other study ID #: 1VIT05006
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2008
• Last updated: August 21, 2008
• Start date: June 2005

Study information

• Verified date: August 2008
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• AST or 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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• VIT-45

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability