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

American Regent

Status: Completed

Conditions: Iron Deficiency Anemia (IDA)

Study type: Observational

Funder types: Industry

Identifiers

NCT01984554

1VIT13033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 551 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

551 participants in 4 patient groups

Ferric Carboxymaltose (FCM)

Description:

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

Description:

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

Description:

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

Ferumoxytol

Description:

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