Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

Iron Deficiency Anemia Clinical Trial

Official title:

A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982007
• Other study ID #: 1VIT09031
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2009
• Last updated: January 22, 2018
• Start date: September 2009
• Est. completion date: August 2011

Study information

• Verified date: January 2018
• Source: Luitpold Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 997
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects = to 18 years of age and able to give informed consent.

• Diagnosis of Iron Deficiency Anemia (IDA).

• Hemoglobin (Hgb) = to 11 g/dL.

• Ferritin = to 100 ng/mL or = 300 when Transferrin Saturation (TSAT) was = 30%.

• Must demonstrate an unsatisfactory response or intolerance to oral iron.

Exclusion Criteria:

• Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.

• Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).

• Requires dialysis for treatment of chronic kidney disease.

• No evidence of iron deficiency.

• Any non-viral infection.

• AST or ALT at screen 1, 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 disorders 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 females who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Ferric Carboxymaltose (FCM)
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
• Ferrous Sulfate Tablets
325 mg Ferrous Sulfate tablets taken orally three times a day
• IV Iron (standard of care)
IV standard of care (other IV iron) per the Investigator's discretion
• Ferric Carboxymaltose (FCM)
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals, Inc.	Norristown	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.		Day 35