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Trial record 62 of 380 for:    FERRIC CATION

Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding

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ClinicalTrials.gov Identifier: NCT01307007
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : June 27, 2017
Last Update Posted : February 16, 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 Iron Deficiency Anemia
Interventions Drug: Ferric Carboxymaltose (FCM)
Drug: Iron Dextran Injection
Enrollment 69
Recruitment Details Hospitals and medical clinics
Pre-assignment Details In the FCM group, reasons for discontinuation prior to dosing included lost to follow-up (5 subjects), subject request (2 subjects), and selection criteria/study compliance (2 subjects). In the iron dextran group, reasons for discontinuation prior to dosing included subject request (4 subjects) and lost to follow-up (1 subject).
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran Injection
Hide Arm/Group Description Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0 Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
Period Title: Overall Study
Started 25 30
Completed 25 30
Not Completed 0 0
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran Injection Total
Hide Arm/Group Description Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0 Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available. Total of all reporting groups
Overall Number of Baseline Participants 25 30 55
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 30 participants 55 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
30
 100.0%
55
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 30 participants 55 participants
36.8  (10.26) 33.7  (10.72) 35.1  (10.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 30 participants 55 participants
Female
25
 100.0%
30
 100.0%
55
 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 25 participants 30 participants 55 participants
25 30 55
1.Primary Outcome
Title Changes in Blood Markers
Hide Description Changes in blood markers of phosphate
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran Injection
Hide Arm/Group Description:
Ferric Carboxymaltose (FCM): 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
Iron Dextran Injection: Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
Overall Number of Participants Analyzed 21 26
Mean (Standard Deviation)
Unit of Measure: mg/dL
-.38  (.878) -.08  (.633)
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Dextran Injection
Hide Arm/Group Description Ferric Carboxymaltose (FCM) : 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0 Iron Dextran Injection : Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
All-Cause Mortality
Ferric Carboxymaltose (FCM) Iron Dextran Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Iron Dextran Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/30 (0.00%) 
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 Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   12/25 (48.00%)   14/30 (46.67%) 
Gastrointestinal disorders     
Nausea * 1  1/25 (4.00%)  2/30 (6.67%) 
General disorders     
Edema peripheral * 1  0/25 (0.00%)  2/30 (6.67%) 
Immune system disorders     
Hypersensitivity * 1  2/25 (8.00%)  1/30 (3.33%) 
Infections and infestations     
Sinusitis * 1  0/25 (0.00%)  2/30 (6.67%) 
Urinary tract infection * 1  1/25 (4.00%)  2/30 (6.67%) 
Metabolism and nutrition disorders     
Hypophosphatemia * 1  8/25 (32.00%)  1/30 (3.33%) 
Musculoskeletal and connective tissue disorders     
Myalgia * 1  0/25 (0.00%)  2/30 (6.67%) 
Skin and subcutaneous tissue disorders     
Urticaria * 1  0/25 (0.00%)  2/30 (6.67%) 
*
Indicates events were collected by non-systematic assessment
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: Sumita Chowdhury, MD, MPH, FACC, MBA
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
EMail: SChowdhury@lpicrd.com
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT01307007     History of Changes
Other Study ID Numbers: 1VIT08023
First Submitted: October 4, 2010
First Posted: March 2, 2011
Results First Submitted: July 22, 2015
Results First Posted: June 27, 2017
Last Update Posted: February 16, 2018