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

N/ACompletedNCT01984554

American Regent, Inc.551 enrolled

Overview

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

551

Conditions

Iron Deficiency Anemia (IDA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, United States

Outcomes

Primary Outcomes

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).

Time frame: 30 day observation period

Data from ClinicalTrials.gov

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