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
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Drug: Ferric Carboxymaltose (FCM) Drug: Iron Sucrose / Iron Dextran||Phase 2|
This was a Phase 2a, open-label, multicenter, randomized study that compared the safety and oxidative stress potential of FCM vs. IV iron sucrose or IV iron dextran in female subjects with IDA. Subjects with a diagnosis of IDA who required iron supplementation met all inclusion and no exclusion criteria, and had given informed consent were randomized. The duration of the study for each subject was a maximum of 6 weeks.
Eligible subjects were randomized in a 1:1 ratio to FCM (Group A) or IV iron sucrose or IV iron dextran (Group B).
Group A subjects received a single undiluted dose of iron as FCM by a slow IV injection on Day 0. Cohort I received 500 mg and Cohort II received 750 mg. Group B subjects received a single dose of iron as IV iron sucrose or as IC iron dextran on Day 0. Cohort I receive 500 mg iron sucrose and Cohort II received 750 mg iron dextran. Iron dextran administration was preceded by a 25 mg test dose 1 hour prior to infusion.
All subjects had laboratory assessments at Baseline, 2 hours post-infusion, 24 hours post-infusion, Day 7 (drawn at the same time of day [within 4 hours] as the 24-hour visit), and Day 30 (drawn at the same time of day [within 4 hours] as the the 24-hour visit). On Days 7 and 30, the safety evalutation for all subjects included treatment-emergent adverse event reporting, concomitant medication review, physical examination including vital signs, and laboratory assessments. Any subject who withdrew from the study received a follow-up phone call 30 days after they received study drug.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled Study to Investigate the Safety and Oxidative Stress Potential of Intravenous Ferric Carboxymaltose (FCM) vs. IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women|
|Actual Study Start Date :||August 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||August 2013|
Experimental: Ferric Carboxymaltose (FCM)
Drug: Ferric Carboxymaltose (FCM)
One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
Other Name: Injectafer
Active Comparator: Iron Sucrose / Iron Dextran
Drug: 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)
Other Name: Venofer, Dexferrum
- Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane) [ Time Frame: Change from Baseline to Day 30 ]
- Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane) [ Time Frame: Change from baseline to 2 hours post end IV infusion ]
- Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane) [ Time Frame: Change from baseline to 24 hours post end IV infusion ]
- Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane) [ Time Frame: Change from baseline to Day 7 post end IV infusion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290315
|United States, Pennsylvania|
|Luitpold Pharmaceuticals, Inc.|
|Norristown, Pennsylvania, United States, 19403|
|Study Director:||Linda M Mundy, MD, PhD||Luitpold Pharmaceuticals|