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

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ferric Carboxymaltose (FCM)

Iron Sucrose / Iron Dextran

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Luitpold Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferric Carboxymaltose (FCM)

Iron Sucrose / Iron Dextran

Arm Description

Intravenous iron

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01290315

First Posted

November 10, 2010

Last Updated

February 2, 2018

Sponsor

American Regent, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01290315

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

August 2009 (Actual)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American Regent, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This was a Phase 2a, open-label, multicenter, randomized study that compared the safety and oxidative stress potential of FCM vs. IV iron sucrose or IV iron dextran in female subjects with IDA. Subjects with a diagnosis of IDA who required iron supplementation met all inclusion and no exclusion criteria, and had given informed consent were randomized. The duration of the study for each subject was a maximum of 6 weeks. Eligible subjects were randomized in a 1:1 ratio to FCM (Group A) or IV iron sucrose or IV iron dextran (Group B). Group A subjects received a single undiluted dose of iron as FCM by a slow IV injection on Day 0. Cohort I received 500 mg and Cohort II received 750 mg. Group B subjects received a single dose of iron as IV iron sucrose or as IC iron dextran on Day 0. Cohort I receive 500 mg iron sucrose and Cohort II received 750 mg iron dextran. Iron dextran administration was preceded by a 25 mg test dose 1 hour prior to infusion. All subjects had laboratory assessments at Baseline, 2 hours post-infusion, 24 hours post-infusion, Day 7 (drawn at the same time of day [within 4 hours] as the 24-hour visit), and Day 30 (drawn at the same time of day [within 4 hours] as the the 24-hour visit). On Days 7 and 30, the safety evalutation for all subjects included treatment-emergent adverse event reporting, concomitant medication review, physical examination including vital signs, and laboratory assessments. Any subject who withdrew from the study received a follow-up phone call 30 days after they received study drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ferric Carboxymaltose (FCM)

Arm Type

Experimental

Arm Description

Intravenous iron

Arm Title

Iron Sucrose / Iron Dextran

Arm Type

Active Comparator

Arm Description

Intravenous iron

Intervention Type

Drug

Intervention Name(s)

Ferric Carboxymaltose (FCM)

Other Intervention Name(s)

Injectafer

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Iron Sucrose / Iron Dextran

Other Intervention Name(s)

Venofer, Dexferrum

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Time Frame

Change from Baseline to Day 30

Title

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

Time Frame

Change from baseline to 2 hours post end IV infusion

Title

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

Time Frame

Change from baseline to 24 hours post end IV infusion

Title

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

Time Frame

Change from baseline to Day 7 post end IV infusion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda M Mundy, MD, PhD

Organizational Affiliation

American Regent, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Luitpold Pharmaceuticals, Inc.

City

Norristown

State/Province

Pennsylvania

ZIP/Postal Code

19403

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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