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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Ferric Carboxymaltose (FCM); Drug: Standard Medical Care (SMC) for the treatment of IDA

• Registration Number: NCT00703937
• 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 First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Study Start: 2008-07
• 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: 708

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric Carboxymaltose (FCM)	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).
Standard Medical Care (SMC) for the treatment of IDA	Standard Medical Care (SMC) for the treatment of IDA	SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).

Primary Outcome Measures

Name	Time	Method
Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC	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

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States