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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01984554

Enrollment

551

Registered

2013-11-14

Start date

2013-09-30

Completion date

2014-12-31

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia (IDA)

Brief summary

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.

Detailed description

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results