Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia

NCT00704028 | Completed Phase 3 Results DMC

• 1 other identifier: 1VIT08020
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)

  Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer

Study Arms (2)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.

Drug: Ferric Carboxymaltose

Iron Dextran

ACTIVE COMPARATOR

As determined by the investigator to a maximum cumulative dose of 2,250 mg.

Drug: Iron Dextran

Interventions

Ferric Carboxymaltose DRUG

15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.

Ferric Carboxymaltose (FCM)

Iron Dextran DRUG

As determined by the investigator to a maximum cumulative dose of 2,250 mg.

Also known as: Dexferrum, INFeD

Iron Dextran

Eligibility Criteria

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

You may qualify if:

• Subjects ≥18 years of age and able to give informed consent
• Iron deficiency is the primary etiology of anemia
• History of intolerance or an unsatisfactory response to oral iron
• Screening Visit central laboratory Hgb ≤11 g/dL
• Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

You may not qualify if:

• Previous participation in a FCM trial
• Known hypersensitivity reaction to FCM or iron dextran
• Requires dialysis for treatment of chronic kidney disease
• Current anemia not attributed to iron deficiency
• Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
• Anticipated need for surgery during the 30 day period prior to screening or during the study period
• AST or ALT greater than 1.5 times the upper limit of normal
• Received an investigational drug within 30 days of screening
• Women who are breastfeeding
• Pregnant or sexually-active females who are not willing to use an effective form of birth control

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610-650-4200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 24, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2011
• Last Updated: February 20, 2018
• Results First Posted: November 25, 2013

Record last verified: 2018-01

Locations

US (1)