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

This study has been completed.

Sponsored by:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00740246

Purpose

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

Condition	Intervention	Phase
Anemia	Drug: VIT-45	Phase III

MedlinePlus related topics: Anemia

Drug Information available for: Ferric carboxymaltose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
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

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

Safety and Tolerability

Study Start Date:

June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740246

Locations

United States, Pennsylvania
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

Luitpold Pharmaceuticals

More Information

Publications of Results:

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.

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.

Study ID Numbers:	1VIT05006
Study First Received:	August 21, 2008
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00740246
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Hematologic Diseases
Anemia
Iron Metabolism Disorders

Metabolic disorder
Iron
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Anemia, Hypochromic

ClinicalTrials.gov processed this record on January 16, 2009