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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

551 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiency Anemia (IDA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Ferumoxytol

Dosing levels, treatment choice, number and scheduling of infusions are all at the discretion of the subject and the subject's prescribing physician

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No