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OpenTrials
Completed

NCT Number: NCT01984554

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

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.

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Key information

Conditions

Iron Deficiency Anemia (IDA) Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 14, 2013
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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