Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

NCT01290315 | Completed Phase 2 Results

• 1 other identifier: 1VIT08022
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects.

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (4)

• Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

  Change from Baseline to Day 30

• Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

  Change from baseline to 2 hours post end IV infusion

• Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

  Change from baseline to 24 hours post end IV infusion

• Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)

  Change from baseline to Day 7 post end IV infusion

Study Arms (2)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

Intravenous iron

Drug: Ferric Carboxymaltose (FCM)

Iron Sucrose / Iron Dextran

ACTIVE COMPARATOR

Intravenous iron

Drug: Iron Sucrose / Iron Dextran

Interventions

Ferric Carboxymaltose (FCM) DRUG

One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)

Also known as: Injectafer

Ferric Carboxymaltose (FCM)

Iron Sucrose / Iron Dextran DRUG

One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Also known as: Venofer, Dexferrum

Iron Sucrose / Iron Dextran

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects 18-50 years of age and able to give informed consent.
• If post-partum, at least 10 days post delivery at Day 0.
• Screening Visit local laboratory Hgb \< or = to 10 g/dL or \< or = to 12 g/dL with symptoms (dizziness and/or fatigue).
• Screening Visit ferritin \< or = to 100 ng/mL or \< or = to 300 when TSAT is \< or = to 30%.
• Documented unsatisfactory response or intolerance to oral iron.

You may not qualify if:

• Previous participation in a ferric carboxymaltose (FCM) clinical trial.
• Known hypersensitivity reaction to any component of ferric carboxymaltose, Venofer, or Dexferrum.
• History of drug allergy or any history of rheumatoid arthritis or other autoimmune diseases.
• Current anemia not attributed to iron deficiency.
• During the 10 day period prior to screening has been treated with antibiotics.
• During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents.
• During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia.
• Current (acute or chronic) infection other than viral upper respiratory tract infection.
• AST or ALT at screening greater than 1.5 times the upper limit of normal.
• Known positive hepatitis B with evidence of active hepatitis.
• Known positive HIV-1/HIV-2 antibodies (anti-HIV).
• Patient has an active diagnosis of asthma and is currently using an anti- asthmatic therapy.
• Received an investigational drug within 30 days of screening.
• Alcohol or drug abuse within the past 6 months.
• Hemochromatosis or other iron storage disorders.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferric carboxymaltose; Ferric Oxide, Saccharated; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Coordination Complexes; Dextrans; Glucans; Polysaccharides

Results Point of Contact

• Title: Angelia Butcher
• Organization: Luitpold Pharmaceuticals, Inc.

abutcher@luitpold.com

610-650-4200

Study Officials

• Linda M Mundy, MD, PhD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: February 7, 2011
• Study Start: August 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 8, 2018
• Results First Posted: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)