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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Ferric Carboxymaltose; Drug: Standard Medical Care (SMC)

• Registration Number: NCT00704353
• Lead Sponsor: American Regent, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2009-07
• Study Completion: 2011-03
• Results First Submitted: 2013-09-16
• Results First Submitted QC: 2013-09-16
• Results First Posted: 2013-11-25
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 735

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States