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

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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:
Information provided by (Responsible Party):
American Regent, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anemia
Interventions Drug: Ferric Carboxymaltose (FCM)
Drug: Standard Medical Care (SMC) for the treatment of IDA
Enrollment 708
Recruitment Details Hospitals and medical clinics
Pre-assignment Details 5 subjects randomized into the trial were discontinued prior to dosing.
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care (SMC) for the Treatment of IDA
Hide Arm/Group Description 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). SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
Period Title: Overall Study
Started 343 360
Completed 278 267
Not Completed 65 93
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care (SMC) for the Treatment of IDA Total
Hide Arm/Group Description 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). SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). Total of all reporting groups
Overall Number of Baseline Participants 343 360 703
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants 360 participants 703 participants
<=18 years
1
   0.3%
3
   0.8%
4
   0.6%
Between 18 and 65 years
267
  77.8%
287
  79.7%
554
  78.8%
>=65 years
75
  21.9%
70
  19.4%
145
  20.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 343 participants 360 participants 703 participants
49.3  (18.48) 47.7  (17.62) 48.5  (18.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 343 participants 360 participants 703 participants
Female
292
  85.1%
318
  88.3%
610
  86.8%
Male
51
  14.9%
42
  11.7%
93
  13.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 343 participants 360 participants 703 participants
343 360 703
1.Primary Outcome
Title Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC
Hide Description 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
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care (SMC) for the Treatment of IDA
Hide Arm/Group Description:
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).
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
Overall Number of Participants Analyzed 343 360
Measure Type: Number
Unit of Measure: participants
17 11
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care (SMC) for the Treatment of IDA
Hide Arm/Group Description 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). SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
All-Cause Mortality
Ferric Carboxymaltose (FCM) Standard Medical Care (SMC) for the Treatment of IDA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Standard Medical Care (SMC) for the Treatment of IDA
Affected / at Risk (%) Affected / at Risk (%)
Total   17/343 (4.96%)   11/360 (3.06%) 
Blood and lymphatic system disorders     
Anemia  1/343 (0.29%)  2/360 (0.56%) 
Cardiac disorders     
Atrial fibrillation  1/343 (0.29%)  0/360 (0.00%) 
Coronary artery disease  1/343 (0.29%)  0/360 (0.00%) 
Ear and labyrinth disorders     
Meniere's disease  0/343 (0.00%)  1/360 (0.28%) 
Gastrointestinal disorders     
Abdominal pain lower  1/343 (0.29%)  0/360 (0.00%) 
Ascites  1/343 (0.29%)  0/360 (0.00%) 
Constipation  1/343 (0.29%)  0/360 (0.00%) 
Gastric ulcer  0/343 (0.00%)  1/360 (0.28%) 
Gastrointestinal hemorrhage  2/343 (0.58%)  1/360 (0.28%) 
Hemorrhoids  1/343 (0.29%)  0/360 (0.00%) 
General disorders     
Chest pain  0/343 (0.00%)  1/360 (0.28%) 
Infections and infestations     
Cellulitis  0/343 (0.00%)  1/360 (0.28%) 
Injury, poisoning and procedural complications     
Femur fracture  1/343 (0.29%)  0/360 (0.00%) 
Metabolism and nutrition disorders     
Hypoglycemia  1/343 (0.29%)  0/360 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1/343 (0.29%)  0/360 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer in situ  0/343 (0.00%)  1/360 (0.28%) 
Colon cancer  1/343 (0.29%)  0/360 (0.00%) 
Rectal cancer  1/343 (0.29%)  0/360 (0.00%) 
Nervous system disorders     
Cartoid artery stenosis  1/343 (0.29%)  0/360 (0.00%) 
Facial palsy  1/343 (0.29%)  0/360 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1/343 (0.29%)  0/360 (0.00%) 
Renal infarct  0/343 (0.00%)  1/360 (0.28%) 
Reproductive system and breast disorders     
Menorrhagia  0/343 (0.00%)  2/360 (0.56%) 
Vascular disorders     
Hypertensive crisis  1/343 (0.29%)  0/360 (0.00%) 
Hypotension  0/343 (0.00%)  1/360 (0.28%) 
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferric Carboxymaltose (FCM) Standard Medical Care (SMC) for the Treatment of IDA
Affected / at Risk (%) Affected / at Risk (%)
Total   41/343 (11.95%)   71/360 (19.72%) 
Gastrointestinal disorders     
Constipation  12/343 (3.50%)  26/360 (7.22%) 
Nausea  14/343 (4.08%)  27/360 (7.50%) 
Nervous system disorders     
Headache  16/343 (4.66%)  18/360 (5.00%) 
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark A. Falone, MD
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
EMail: mfalone@luitpold.com
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00703937     History of Changes
Other Study ID Numbers: 1VIT08019
First Submitted: June 20, 2008
First Posted: June 24, 2008
Results First Submitted: September 16, 2013
Results First Posted: November 25, 2013
Last Update Posted: February 20, 2018