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

April 16, 2025 updated by: American Regent, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

594

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIT-45 on Day 0, then Placebo on Day 7

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.
Drug: VIT-45
15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously
Other Names:
  • ferric carboxymaltose
Drug: Placebo
for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously
Experimental: Placebo on Day 0, then VIT-45 on Day 7

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.
Drug: VIT-45
15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously
Other Names:
  • ferric carboxymaltose
Drug: Placebo
for weight >33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent Adverse Events During Each 7-day Study Period
Time Frame: Day 0 to 7
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.
Day 0 to 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Regent, Inc.

Investigators

  • Study Director: David Bregman, MD, American Regent, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimated)

August 22, 2008

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1VIT05006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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