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

Sponsor

American Regent, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01984554

Collaborator

(none)

551

Enrollment

Location

Duration (Months)

36.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia (IDA)

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

551 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luitpold Pharmaceuticals, Inc.	Norristown	Pennsylvania	United States	19403

Sponsors and Collaborators

American Regent, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

American Regent, Inc.

ClinicalTrials.gov Identifier:

NCT01984554

Other Study ID Numbers:

1VIT13033

First Posted:

Nov 14, 2013

Last Update Posted:

Jan 24, 2018

Last Verified:

Jan 1, 2018

Additional relevant MeSH terms:

Anemia

Anemia, Iron-Deficiency

Deficiency Diseases

Study Results

No Results Posted as of Jan 24, 2018