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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: VIT-45; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00740246

1VIT05006

Details and patient eligibility

About

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

Full description

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

Enrollment: 594 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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594 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: VIT-45

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

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: VIT-45