Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
Completed
- Conditions
- Iron Deficiency Anemia (IDA)
- Registration Number
- NCT01984554
- Lead Sponsor
- American Regent, Inc.
- 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
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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Luitpold Pharmaceuticals, Inc.
🇺🇸Norristown, Pennsylvania, United States