Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function

NCT ID: NCT00981045

Last Updated: 2018-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2561 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-08-31

Brief Summary

The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.

Conditions

Iron Deficiency Anemia; Impaired Renal Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric Carboxymaltose (FCM)

2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg

Group Type: EXPERIMENTAL

Ferric Carboxymaltose (FCM)

Intervention Type: DRUG

2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg

Iron Sucrose (Venofer)

5 doses of 200 mg for a total cumulative dose of 1000 mg

Group Type: ACTIVE_COMPARATOR

Iron Sucrose (Venofer)

Intervention Type: DRUG

5 doses of 200 mg for a total cumulative dose of 1000 mg

Interventions

Ferric Carboxymaltose (FCM)

2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg

Intervention Type: DRUG

Iron Sucrose (Venofer)

5 doses of 200 mg for a total cumulative dose of 1000 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subjects > or = to 18 years of age.
• Chronically impaired renal function.
• Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
• Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
• If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria

• Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
• Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
• Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
• No evidence of iron deficiency.
• Any non-viral infection.
• AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
• Known positive hepatitis with evidence of active disease.
• Received an investigational drug within 30 days of screening.
• Alcohol or drug abuse within the past 6 months.
• Hemochromatosis or other iron storage disorders.
• Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
• Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
• Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, United States

Countries

United States

Other Identifiers

1VIT09030

Identifier Type: -

Identifier Source: org_study_id