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Trial record 90 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT00704028
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: Iron Dextran
Enrollment 161
Recruitment Details Hospitals and medical clinics
Pre-assignment Details One subject randomized to iron dextran never received study drug and was discontinued due to subject request.
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran
Hide Arm/Group Description 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg. As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Period Title: Overall Study
Started 82 78 [1]
Completed 70 57
Not Completed 12 21
[1]
A subject randomized to iron dextran never received study drug and was d/c due to subject request.
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran Total
Hide Arm/Group Description 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg. As determined by the investigator to a maximum cumulative dose of 2,250 mg. Total of all reporting groups
Overall Number of Baseline Participants 82 78 160
Hide Baseline Analysis Population Description
Safety population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 78 participants 160 participants
<=18 years
0
   0.0%
1
   1.3%
1
   0.6%
Between 18 and 65 years
72
  87.8%
62
  79.5%
134
  83.8%
>=65 years
10
  12.2%
15
  19.2%
25
  15.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants 78 participants 160 participants
46.2  (14.64) 48.2  (17.10) 47.2  (15.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 78 participants 160 participants
Female
73
  89.0%
69
  88.5%
142
  88.8%
Male
9
  11.0%
9
  11.5%
18
  11.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 82 participants 78 participants 160 participants
82 78 160
1.Primary Outcome
Title The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)
Hide Description [Not Specified]
Time Frame Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran
Hide Arm/Group Description:
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Overall Number of Participants Analyzed 82 78
Measure Type: Number
Unit of Measure: participants
60 59
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran
Hide Arm/Group Description 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg. As determined by the investigator to a maximum cumulative dose of 2,250 mg.
All-Cause Mortality
Ferric Carboxymaltose (FCM) Iron Dextran
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Iron Dextran
Affected / at Risk (%) Affected / at Risk (%)
Total   5/82 (6.10%)   3/78 (3.85%) 
Cardiac disorders     
Atrial fibrillation  0/82 (0.00%)  1/78 (1.28%) 
Gastrointestinal disorders     
Abdominal pain  1/82 (1.22%)  0/78 (0.00%) 
Crohn's disease  1/82 (1.22%)  0/78 (0.00%) 
General disorders     
Asthenia  1/82 (1.22%)  0/78 (0.00%) 
Death  1/82 (1.22%)  0/78 (0.00%) 
Immune system disorders     
Anaphylactic reaction  0/82 (0.00%)  1/78 (1.28%) 
Hypersensitivity  0/82 (0.00%)  1/78 (1.28%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer recurrent  1/82 (1.22%)  0/78 (0.00%) 
Nervous system disorders     
Syncope  2/82 (2.44%)  0/78 (0.00%) 
Vascular disorders     
Vascular pseudoaneurysm  0/82 (0.00%)  1/78 (1.28%) 
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) Iron Dextran
Affected / at Risk (%) Affected / at Risk (%)
Total   45/82 (54.88%)   54/78 (69.23%) 
Gastrointestinal disorders     
Diarrhea  5/82 (6.10%)  3/78 (3.85%) 
Nausea  12/82 (14.63%)  8/78 (10.26%) 
Vomiting  5/82 (6.10%)  4/78 (5.13%) 
Immune system disorders     
Hypersensitivity  0/82 (0.00%)  7/78 (8.97%) 
Metabolism and nutrition disorders     
Hypophosphatemia  7/82 (8.54%)  0/78 (0.00%) 
Nervous system disorders     
Dizziness  6/82 (7.32%)  4/78 (5.13%) 
Headache  6/82 (7.32%)  10/78 (12.82%) 
Skin and subcutaneous tissue disorders     
Pruritus  2/82 (2.44%)  6/78 (7.69%) 
Rash  2/82 (2.44%)  5/78 (6.41%) 
Urticaria  0/82 (0.00%)  7/78 (8.97%) 
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: NCT00704028     History of Changes
Other Study ID Numbers: 1VIT08020
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