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

American Regent, Inc.594 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

594

Conditions

Anemia

Interventions

VIT-45DRUG

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

PlaceboDRUG

for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Day 0 to 7

Data from ClinicalTrials.gov

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