Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia

The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia (IDA)

Detailed Description

The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who receive iron sucrose, iron dextran, and ferumoxytol.

• Study Type: Observational
• Enrollment (Actual): 551

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects presenting for IDA treatment

Description

Inclusion Criteria:

• Must present for the first dose of a current cycle of IV treatment for IDA
• Must be over 18 years of age
• Must be willing and able to provide informed consent, including permission to obtain information from their medical records.
• Must be able to read and understand English.

Exclusion Criteria:

• Subjects not diagnosed with IDA.
• Subjects requiring more than one treatment cycle within 30 days.
• Subjects receiving maintenance IV iron therapy.
• Subjects treated with IV iron within the 30-day period prior to study enrollment.
• Subjects who received investigational medication in the six months prior to the study.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Ferric Carboxymaltose (FCM); Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician.
Iron Sucrose; Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician
Iron Dextran; Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician
Ferumoxytol; Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Site costs of administering IV iron to subjects to be assessed by applying unit costs to information collected directly on the eCRF (electronic Case Report Form).	30 day observation period

Collaborators and Investigators

• Sponsor: American Regent, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: November 8, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (ESTIMATE): November 14, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2018
• Last Update Submitted That Met QC Criteria: January 22, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases
• Other Study ID Numbers: 1VIT13033