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Trial record 24 of 46 for:    FERRIC SULFATE

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

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ClinicalTrials.gov Identifier: NCT00704353
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
Drug: Standard Medical Care (SMC)
Enrollment 735
Recruitment Details Hospitals and medical clinics
Pre-assignment Details  
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care
Hide Arm/Group Description Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. Subjects received standard medical care (as determined by the Investigator) for treatment of IDA.
Period Title: Overall Study
Started 366 369
Completed 268 255
Not Completed 98 114
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care Total
Hide Arm/Group Description Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. Subjects received standard medical care (as determined by the Investigator) for treatment of IDA. Total of all reporting groups
Overall Number of Baseline Participants 366 369 735
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 366 participants 369 participants 735 participants
<=18 years
3
   0.8%
6
   1.6%
9
   1.2%
Between 18 and 65 years
266
  72.7%
265
  71.8%
531
  72.2%
>=65 years
97
  26.5%
98
  26.6%
195
  26.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 366 participants 369 participants 735 participants
49.2  (19.94) 49.6  (19.88) 49.4  (19.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 366 participants 369 participants 735 participants
Female
322
  88.0%
315
  85.4%
637
  86.7%
Male
44
  12.0%
54
  14.6%
98
  13.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 366 participants 369 participants 735 participants
366 369 735
1.Primary Outcome
Title Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
Hide Description [Not Specified]
Time Frame through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care
Hide Arm/Group Description:
Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0.
Received standard medical care (as determined by the Investigator) of IDA.
Overall Number of Participants Analyzed 366 369
Measure Type: Number
Unit of Measure: participants
5 9
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Standard Medical Care
Hide Arm/Group Description Subjects received an undiluted dose of iron as FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. Received standard medical care (as determined by the Investigator) of IDA.
All-Cause Mortality
Ferric Carboxymaltose (FCM) Standard Medical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Standard Medical Care
Affected / at Risk (%) Affected / at Risk (%)
Total   5/366 (1.37%)   9/369 (2.44%) 
Blood and lymphatic system disorders     
Iron deficiency anemia  1/366 (0.27%)  0/369 (0.00%) 
Leukocytosis  1/366 (0.27%)  0/369 (0.00%) 
Cardiac disorders     
Angina pectoris  0/366 (0.00%)  1/369 (0.27%) 
Atrial fibrillation  1/366 (0.27%)  0/369 (0.00%) 
Cardiomyopathy  1/366 (0.27%)  0/369 (0.00%) 
Coronary artery disease  0/366 (0.00%)  1/369 (0.27%) 
Gastrointestinal disorders     
Food poisoning  0/366 (0.00%)  1/369 (0.27%) 
Gastrointestinal hemorrhage  1/366 (0.27%)  0/369 (0.00%) 
General disorders     
Pyrexia  0/366 (0.00%)  1/369 (0.27%) 
Infections and infestations     
Pneumonia  0/366 (0.00%)  2/369 (0.54%) 
Injury, poisoning and procedural complications     
Inappropriate device stimulation of tissue  1/366 (0.27%)  0/369 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1/366 (0.27%)  0/369 (0.00%) 
Diabetic ketoacidosis  0/366 (0.00%)  1/369 (0.27%) 
Nervous system disorders     
Neuropathy  0/366 (0.00%)  1/369 (0.27%) 
Renal and urinary disorders     
Renal failure acute  0/366 (0.00%)  1/369 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory distress  1/366 (0.27%)  0/369 (0.00%) 
Vascular disorders     
Hypertension  0/366 (0.00%)  1/369 (0.27%) 
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
Affected / at Risk (%) Affected / at Risk (%)
Total   0/366 (0.00%)   0/369 (0.00%) 
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
Name/Title: Mark Falone, MD
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00704353     History of Changes
Other Study ID Numbers: 1VIT08021
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