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Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354484
Recruitment Status : Completed
First Posted : July 20, 2006
Results First Posted : December 5, 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 Postpartum Anemia
Interventions Drug: Ferric Carboxymaltose (FCM)
Drug: Ferrous Sulfate tablets
Enrollment 291
Recruitment Details Hospitals and medical clinics
Pre-assignment Details 1 subject in each group were discontinued from the study prior to dosing due to subject request.
Arm/Group Title Ferric Carboxymaltose (FCM) Ferrous Sulfate Tablets
Hide Arm/Group Description Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Period Title: Overall Study
Started 142 147
Completed 138 144
Not Completed 4 3
Arm/Group Title Ferric Carboxymaltose (FCM) Ferrous Sulfate Tablets Total
Hide Arm/Group Description Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 142 147 289
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 147 participants 289 participants
<=18 years
14
   9.9%
7
   4.8%
21
   7.3%
Between 18 and 65 years
128
  90.1%
140
  95.2%
268
  92.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants 147 participants 289 participants
26.43  (6.02) 26.49  (5.55) 26.45  (5.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 147 participants 289 participants
Female
142
 100.0%
147
 100.0%
289
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 142 participants 147 participants 289 participants
142 147 289
1.Primary Outcome
Title Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL
Hide Description [Not Specified]
Time Frame anytime between baseline and end of study or time to intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Carboxymaltose (FCM) Ferrous Sulfate Tablets
Hide Arm/Group Description:
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
Overall Number of Participants Analyzed 142 147
Measure Type: Number
Unit of Measure: participants
127 98
2.Primary Outcome
Title Reported Adverse Events
Hide Description [Not Specified]
Time Frame anytime between baseline and end of study or time to intervention
Outcome Measure Data Not Reported
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Ferrous Sulfate Tablets
Hide Arm/Group Description Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly. 325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
All-Cause Mortality
Ferric Carboxymaltose (FCM) Ferrous Sulfate Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Ferrous Sulfate Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   4/142 (2.82%)   4/147 (2.72%) 
Cardiac disorders     
Mitral valve prolapse  1/142 (0.70%)  0/147 (0.00%) 
Gastrointestinal disorders     
Hemorrhoids  1/142 (0.70%)  0/147 (0.00%) 
Hepatobiliary disorders     
Cholecystitis acute  1/142 (0.70%)  0/147 (0.00%) 
Infections and infestations     
Pyelonephritis  1/142 (0.70%)  0/147 (0.00%) 
Endometritis  0/142 (0.00%)  2/147 (1.36%) 
Pelvic abscess  0/142 (0.00%)  2/147 (1.36%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema  1/142 (0.70%)  0/147 (0.00%) 
Pulmonary embolism  0/142 (0.00%)  1/147 (0.68%) 
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferric Carboxymaltose (FCM) Ferrous Sulfate Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   9/142 (6.34%)   29/147 (19.73%) 
Gastrointestinal disorders     
Constipation  2/142 (1.41%)  18/147 (12.24%) 
Nervous system disorders     
Headache  7/142 (4.93%)  11/147 (7.48%) 
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
Publications of Results:
Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: A Randomized Controlled Study. Southern Medical Association Scientific Assembly 2008.
Seid MH, Rogers R, Dinh Q. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose in a Randomized Controlled Study. American Journal of Obstetrics & Gynecology S26, 2007.
Seid MH, Rogers R, Dinh Q. The Safety and Tolerability of Ferric Carboxymaltose in Treating Postpartum Women with Iron Dediciency Anemia. American College of Obstetrics & Gynecology District Meeting 2007.
Seid MH, Mangione A, Valaoras TG, Anthony LB, Barish CF. Safety Profile of Ferric Carboxymaltose, a New High Dose Intravenous Iron in Patients with Iron Deficiency Anemia. Society for the Advancement of Blood Managment 6th Annual Meeting 2007.
Goodnough LT. Treating Postpartum Anemia with Intravenous Ferric Carboxymaltose: a Randomized Controlled Study. Nordic Conference of Obstetrics & Gynecology 2008.
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00354484    
Other Study ID Numbers: 1VIT06011
First Submitted: July 13, 2006
First Posted: July 20, 2006
Results First Submitted: October 8, 2013
Results First Posted: December 5, 2013
Last Update Posted: February 20, 2018