Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia

• ClinicalTrials.gov Identifier: NCT00703937
• Recruitment Status: Completed
• First Posted: June 24, 2008
• Results First Posted: November 25, 2013
• Last Update Posted: February 20, 2018
• Sponsor: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anemia	Drug: Ferric Carboxymaltose (FCM); Drug: Standard Medical Care (SMC) for the treatment of IDA	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 708 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia
• Study Start Date: July 2008
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ferric Carboxymaltose (FCM); 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).	Drug: Ferric Carboxymaltose (FCM)
Active Comparator: Standard Medical Care (SMC) for the treatment of IDA; SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).	Drug: Standard Medical Care (SMC) for the treatment of IDA

Outcome Measures

Primary Outcome Measures :

1. Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC [ Time Frame: First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer ]
   Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 Hemoglobin (Hgb) ≤ 11g/dL
• Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL 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
• AST or 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 willing to use an effective form of birth control

Contacts and Locations

Locations

United States, Pennsylvania

Luitpold Pharmaceuticals

Norristown, Pennsylvania, United States, 19403

Sponsors and Collaborators

American Regent, Inc.

More Information

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT00703937
• Other Study ID Numbers: 1VIT08019
• First Posted: June 24, 2008
• Results First Posted: November 25, 2013
• Last Update Posted: February 20, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Anemia; Anemia, Iron-Deficiency; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases