Expired Study
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Norristown, Pennsylvania 19403


Purpose:

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.


Criteria:

Inclusion Criteria: - Subjects ≥18 years of age and able to give informed consent - Iron deficiency is the primary etiology of anemia - History of intolerance or an unsatisfactory response to oral iron - Screening Visit central laboratory Hgb ≤11 g/dL - Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30% Exclusion Criteria: - Previous participation in a FCM trial - Known hypersensitivity reaction to FCM or iron dextran - Requires dialysis for treatment of chronic kidney disease - Current anemia not attributed to iron deficiency - Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase - Anticipated need for surgery during the 30 day period prior to screening or during the study period - AST or ALT greater than 1.5 times the upper limit of normal - Received an investigational drug within 30 days of screening - Women who are breastfeeding - Pregnant or sexually-active females who are not willing to use an effective form of birth control


Study is Available At:


Original ID:

1VIT08020


NCT ID:

NCT00704028


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Luitpold Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

161


Enrollment Type:

Actual


Study Dates

Start Date:June 2008
Completion Date:March 2011
Completion Type:Actual
Primary Completion Date:January 2010
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:January 22, 2018
First Received Date:June 20, 2008
First Results Date:September 16, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)
Time Frame:Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was long
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ferric Carboxymaltose
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.
Arm Name:Ferric Carboxymaltose (FCM)
Intervention Type:Drug
Name:Iron Dextran
Description:As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Arm Name:Iron Dextran
Other Name:Dexferrum, INFeD

Study Arms

Study Arm Type:Active Comparator
Arm Name:Iron Dextran
Description:As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Study Arm Type:Experimental
Arm Name:Ferric Carboxymaltose (FCM)
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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Luitpold Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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