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Trial record 56 of 380 for:    FERRIC CATION

Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

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ClinicalTrials.gov Identifier: NCT01290315
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : February 8, 2018
Last Update Posted : February 8, 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 Sucrose / Iron Dextran
Enrollment 49
Recruitment Details Hospitals and Medical Clinics. December 6, 2010 through October 13, 2012.
Pre-assignment Details Discontinuation prior to dosing included lost to follow-up, subject request, and selection criteria/study compliance. A total of 19 subjects were excluded from the population of subjects evaluated for efficacy and safety-5 randomized to FCM 500mg, 2 randomized to FCM 750mg, 6 randomized to iron sucrose 500mg, and 6 randomized to iron dextran 750mg.
Arm/Group Title Ferric Carboxymaltose (FCM) Cohort I Iron Sucrose Cohort I Ferric Carboxymaltose (FCM) Cohort II Iron Dextran Cohort II
Hide Arm/Group Description

Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)

Intravenous iron

Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)

Intravenous iron

Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)

Intravenous iron

Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Period Title: Overall Study
Started 14 12 10 13
Completed 11 9 10 8
Not Completed 3 3 0 5
Reason Not Completed
Adverse Event             0             0             0             3
Selection criteria/compliance             2             1             0             2
Lost to Follow-up             0             1             0             0
Withdrawal by Subject             1             1             0             0
Arm/Group Title Ferric Carboxymaltose (FCM) Cohort I Iron Sucrose Cohort I Ferric Carboxymaltose (FCM) Cohort II Iron Dextran Cohort II Total
Hide Arm/Group Description

Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)

Intravenous iron

Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)

Intravenous iron

Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)

Intravenous iron

Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Total of all reporting groups
Overall Number of Baseline Participants 14 12 10 13 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 10 participants 13 participants 49 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
12
 100.0%
10
 100.0%
13
 100.0%
49
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 12 participants 10 participants 13 participants 49 participants
32.1  (7.66) 29.6  (9.93) 39.2  (7.97) 39.2  (9.21) 34.8  (9.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 12 participants 10 participants 13 participants 49 participants
Female
14
 100.0%
12
 100.0%
10
 100.0%
13
 100.0%
49
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 12 participants 10 participants 13 participants 49 participants
14 12 10 13 49
1.Primary Outcome
Title Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with both a Baseline and at least one post-Baseline value are included.
Arm/Group Title Ferric Carboxymaltose (FCM) Cohort I Iron Sucrose Cohort I Ferric Carboxymaltose (FCM) Cohort II Iron Dextran Cohort II
Hide Arm/Group Description:

Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)

Intravenous iron

Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)

Intravenous iron

Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)

Intravenous iron

Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Overall Number of Participants Analyzed 12 9 10 10
Mean (Standard Deviation)
Unit of Measure: mg
Carbonyl -11.90  (52.55) -1.06  (38.722) -12.37  (32.91) -11.14  (48.57)
8-isoprostane 141.46  (892.16) -369.50  (957.06) 8.83  (81.20) 32.28  (233.41)
2.Primary Outcome
Title Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Hide Description [Not Specified]
Time Frame Change from baseline to 2 hours post end IV infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with both a baseline and at least one post baseline value are included.
Arm/Group Title Ferric Carboxymaltose (FCM) Cohort I Iron Sucrose Cohort I Ferric Carboxymaltose (FCM) Cohort II Iron Dextran Cohort II
Hide Arm/Group Description:

Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)

Intravenous iron

Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)

Intravenous iron

Ferric Carboxymaltose (FCM): One 750mg dose at 100 mg/minute (Cohort II)

Intravenous iron

Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Overall Number of Participants Analyzed 12 10 10 11
Mean (Standard Deviation)
Unit of Measure: mg
Carbonyl Number Analyzed 12 participants 9 participants 9 participants 11 participants
2.07  (38.21) 6.05  (24.69) -8.66  (43.15) -5.98  (23.71)
8-isoprostane Number Analyzed 12 participants 9 participants 9 participants 11 participants
151.59  (833.75) -420.02  (803.52) -2.64  (30.44) -5.92  (216.66)
3.Primary Outcome
Title Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Hide Description [Not Specified]
Time Frame Change from baseline to 24 hours post end IV infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with both a baseline and at least one post baseline value are included.
Arm/Group Title Ferric Carboxymaltose (FCM) Cohort I Iron Sucrose Cohort I Ferric Carboxymaltose (FCM) Cohort II Iron Dextran Cohort II
Hide Arm/Group Description:

Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)

Intravenous iron

Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)

Intravenous iron

Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)

Intravenous iron

Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Overall Number of Participants Analyzed 12 10 10 11
Mean (Standard Deviation)
Unit of Measure: mg
Carbonyl Number Analyzed 11 participants 10 participants 9 participants 11 participants
8.63  (23.24) -6.92  (21.49) 8.94  (87.05) -11.57  (40.30)
8-isoprostane Number Analyzed 11 participants 10 participants 9 participants 11 participants
198.67  (864.29) 119.26  (575.29) -23.96  (60.01) 38.02  (190.07)
4.Primary Outcome
Title Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
Hide Description [Not Specified]
Time Frame Change from baseline to Day 7 post end IV infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with both a baseline and at least one post baseline value are included.
Arm/Group Title Ferric Carboxymaltose (FCM) Cohort I Iron Sucrose Cohort I Ferric Carboxymaltose (FCM) Cohort II Iron Dextran Cohort II
Hide Arm/Group Description:

Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I)

Intravenous iron

Iron Sucrose: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I)

Intravenous iron

Ferric Carboxymaltose (FCM): One 750 mg dose at 100 mg/minute (Cohort II)

Intravenous iron

Iron Dextran: One 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Overall Number of Participants Analyzed 10 8 10 9
Mean (Standard Deviation)
Unit of Measure: mg
Carbonyl 11.69  (36.43) -24.03  (65.55) -18.20  (45.92) -12.10  (54.85)
8-isoprostane 263.52  (896.57) -417.89  (1030.83) -29.35  (56.88) -58.04  (159.58)
Time Frame 1 year and 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Sucrose or Iron Dextran
Hide Arm/Group Description

Intravenous iron

Ferric Carboxymaltose (FCM): One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)

Intravenous iron

Iron Sucrose / Iron Dextran: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

All-Cause Mortality
Ferric Carboxymaltose (FCM) Iron Sucrose or Iron Dextran
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Iron Sucrose or Iron Dextran
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      2/25 (8.00%)    
Immune system disorders     
Anaphylactic Reaction * 1  0/24 (0.00%)  0 2/25 (8.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ferric Carboxymaltose (FCM) Iron Sucrose or Iron Dextran
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/24 (25.00%)      10/25 (40.00%)    
Gastrointestinal disorders     
Nausea * 1  1/24 (4.17%)  1 2/25 (8.00%)  2
Vomiting * 1  0/24 (0.00%)  0 1/25 (4.00%)  1
General disorders     
Injection site bruising * 1  1/24 (4.17%)  1 0/25 (0.00%)  0
Immune system disorders     
Anaphylactic reaction * 1  0/24 (0.00%)  0 2/25 (8.00%)  2
Hypersensitivity * 1  2/24 (8.33%)  2 2/25 (8.00%)  2
Metabolism and nutrition disorders     
Hypophosphataemia * 1  1/24 (4.17%)  1 0/25 (0.00%)  0
Nervous system disorders     
Dizziness * 1  1/24 (4.17%)  1 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash * 1  0/24 (0.00%)  0 2/25 (8.00%)  2
Urticaria * 1  0/24 (0.00%)  0 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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: Angelia Butcher
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200 ext 811
EMail: abutcher@luitpold.com
Layout table for additonal information
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT01290315     History of Changes
Other Study ID Numbers: 1VIT08022
First Submitted: November 10, 2010
First Posted: February 7, 2011
Results First Submitted: June 11, 2015
Results First Posted: February 8, 2018
Last Update Posted: February 8, 2018