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

Iron Deficiency Anemia (IDA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984554
• Other study ID #: 1VIT13033
• Status: Completed
• Phase: N/A
• First received: November 8, 2013
• Last updated: January 22, 2018
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia (IDA)

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals, Inc.	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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