Intravenous Ferric Carboxymaltose (FCM) Versus IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Luitpold Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01290315
First received: November 10, 2010
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Iron Deficiency Anemia
Drug: Ferric Carboxymaltose (FCM)
Drug: Iron Sucrose / Iron Dextran
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study to Investigate the Safety and Oxidative Stress Potential of Intravenous Ferric Carboxymaltose (FCM) vs. IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Changes from baseline in markers of oxidative stress (including glutathione peroxidase, malondialdehyde (MDA), ratio of GSH:GSSG, oxidatively modified proteins and lymphocyte analysis). [ Time Frame: Change from Baseline at Day 0 ] [ Designated as safety issue: Yes ]
  • Changes from baseline in markers of oxidative stress (including glutathione peroxidase, malondialdehyde (MDA), ratio of GSH:GSSG, oxidatively modified proteins and lymphocyte analysis). [ Time Frame: Change from baseline 2 hours post end IV infusion ] [ Designated as safety issue: Yes ]
  • Changes from baseline in markers of oxidative stress (including glutathione peroxidase, malondialdehyde (MDA), ratio of GSH:GSSG, oxidatively modified proteins and lymphocyte analysis). [ Time Frame: Change from baseline 24 hours post end IV infusion ] [ Designated as safety issue: Yes ]
  • Changes from baseline in markers of oxidative stress (including glutathione peroxidase, malondialdehyde (MDA), ratio of GSH:GSSG, oxidatively modified proteins and lymphocyte analysis). [ Time Frame: Change from baseline Day 7 post end IV infusion ] [ Designated as safety issue: Yes ]
  • Changes from baseline in markers of oxidative stress (including glutathione peroxidase, malondialdehyde (MDA), ratio of GSH:GSSG, oxidatively modified proteins and lymphocyte analysis). [ Time Frame: Change from Baseline End of Study (Day 30) post end IV infusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: August 2009
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Carboxymaltose (FCM)
Intravenous iron
Drug: Ferric Carboxymaltose (FCM)
One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
Active Comparator: Iron Sucrose or Iron Dextran
Intravenous iron
Drug: Iron Sucrose / Iron Dextran
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)
Other Name: Venofer, Dexferrum

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary.
  • 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.
  • Systolic blood pressure > or = to 180 or < 80 mmHg or diastolic blood pressure > or = to 100 or < 40 mmHg at screening or Day 0.
  • Chronic kidney disease.
  • Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.
  • Pre-term delivery < 32 weeks.
  • Emergent C-section delivery.
  • Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure.
  • Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
  • Night shift workers.
  • Breastfeeding planned on or after Day 0.
  • Pregnant or sexually-active female subjects who are of childbearing potential and who don't use an acceptable form of contraception.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290315

Contacts
Contact: Angelia Butcher 610-650-4200 ext 811 abutcher@lpicrd.com
Contact: David Bregman, M.D., Ph.D. 610-650-4200 ext 828 dbregman@lpicrd.com

Locations
United States, Pennsylvania
Luitpold Pharmaceuticals, Inc. Recruiting
Norristown, Pennsylvania, United States, 19403
Contact: Angelia Butcher    610-650-4200 ext 811    abutcher@lpicrd.com   
Contact: David Bregman, M.D., Ph.D.    610-650-4200 ext 828    dbregman@lpicrd.com   
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Marc Tokars, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01290315     History of Changes
Other Study ID Numbers: 1VIT08022
Study First Received: November 10, 2010
Last Updated: February 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Dextrans
Iron-Dextran Complex
Ferric oxide, saccharated
Ferric Compounds
Iron
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
Hematinics
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014