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

NCT01984554 | Completed

• 1 other identifier: 1VIT13033
• Study Type: observational
• Target: 551
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia (IDA)

Outcome Measures

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).

  30 day observation period

Study Arms (4)

Ferric Carboxymaltose (FCM)

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

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

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

Ferumoxytol

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects presenting for IDA treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 14, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

US (1)