Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia

Anemia Clinical Trial

Official title:

A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704353
• Other study ID #: 1VIT08021
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2008
• Last updated: January 22, 2018
• Start date: June 2008
• Est. completion date: March 2011

Study information

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

Clinical Trial Summary

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent

Recruitment information / eligibility

• Status: Completed
• Enrollment: 735
• Est. completion date: March 2011
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects =18 years of age and able to give informed consent

• Iron deficiency is the primary etiology of anemia

• Screening Visit central laboratory Hgb indicative of anemia =12 g/dL

• Screening Visit ferritin indicative of iron deficiency anemia =100 ng/mL or =300 when TSAT was =30%

Exclusion Criteria:

• Previous participation in a FCM trial

• Known hypersensitivity reaction to FCM

• Requires dialysis for treatment of chronic kidney disease

• Current anemia not attributed to iron deficiency

• Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase

• Anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period

• AST of ALT greater than 1.5 times the upper limit of normal

• Received an investigational drug within 30 days of screening

• Pregnant or sexually-active females who are not able to use an effective form of birth control

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency

Intervention

Drug:
• Ferric Carboxymaltose
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
• Standard Medical Care (SMC)
Per product label

Locations

Country	Name	City	State
United States	Luitpold Pharmaceuticals	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	Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)		through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)