CompletedNCT00704353Updated Feb 20, 2018Results posted

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

A Phase 3 interventional study of Ferric Carboxymaltose and Standard Medical Care (SMC) in Anemia, sponsored by American Regent, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-20.

Sponsored by American Regent, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 735
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Anemia

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In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 735 is above the median of 94 across 1,291 interventional studies indexed under Anemia.

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Lead sponsor

American Regent, Inc. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 735 participants (actual)

Study arms

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

Interventions

DrugFerric Carboxymaltose
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
DrugStandard Medical Care (SMC)
Per product label
Also known as: Ferrous Sulfate, Venofer, Ferrlecit, Infed, Dexferrum

What researchers measure

Primary outcomes

Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
Time frame: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)

Results

Posted Nov 25, 2013

Participant flow

Hospitals and medical clinics

Participant flow — Overall Study
Milestone	Ferric Carboxymaltose (FCM)	Standard Medical Care
Started	366	369
Completed	268	255
Not completed	98	114

Outcome measures

PrimaryNumber of Participants With Treatment-emergent Serious Adverse Events (SAE's)

Time frame:: through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
Reported as:: Number · participants

Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
participants	Ferric Carboxymaltose (FCM)	Standard Medical Care
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)	5	9

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ferric Carboxymaltose (FCM)	—	5/366 (1.4%)	0/366 (0%)
Standard Medical Care	—	9/369 (2.4%)	0/369 (0%)

Most frequent serious events

Showing 10 of 17

Most frequent serious events
Event	Ferric Carboxymaltose (FCM)	Standard Medical Care
PneumoniaInfections and infestations	0/366	2/369
Iron deficiency anemiaBlood and lymphatic system disorders	1/366	0/369
LeukocytosisBlood and lymphatic system disorders	1/366	0/369
Atrial fibrillationCardiac disorders	1/366	0/369
CardiomyopathyCardiac disorders	1/366	0/369
Gastrointestinal hemorrhageGastrointestinal disorders	1/366	0/369
Inappropriate device stimulation of tissueInjury, poisoning and procedural complications	1/366	0/369
DehydrationMetabolism and nutrition disorders	1/366	0/369
Respiratory distressRespiratory, thoracic and mediastinal disorders	1/366	0/369
Angina pectorisCardiac disorders	0/366	1/369

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Ferric Carboxymaltose (FCM)	Standard Medical Care	Total
<=18 years	3	6	9
Between 18 and 65 years	266	265	531
>=65 years	97	98	195

Age, Continuous
Age, Continuous(years)	Ferric Carboxymaltose (FCM)	Standard Medical Care	Total
Mean	49.2 ± 19.94	49.6 ± 19.88	49.4 ± 19.91

Sex: Female, Male
Sex: Female, Male(Participants)	Ferric Carboxymaltose (FCM)	Standard Medical Care	Total
Female	322	315	637
Male	44	54	98

Region of Enrollment
Region of Enrollment(participants)	Ferric Carboxymaltose (FCM)	Standard Medical Care	Total
United States	366	369	735

Study locations

1 site

Luitpold Pharmaceuticals
Norristown, Pennsylvania 19403, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00704353
Lead sponsor: American Regent, Inc.
Responsible party: Sponsor
First posted: Jun 24, 2008
Start date: Jun 2008
Primary completion: Jul 2009
Completion: Mar 2011
Results posted: Nov 25, 2013
Last update: Feb 20, 2018

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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