Back to resultsSafety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose
Standard Medical Care (SMC)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Subjects ≥18 years of age and able to give informed consent
- Iron deficiency is the primary etiology of anemia
- Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
- Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion Criteria:
- Previous participation in a FCM trial
- Known hypersensitivity reaction to FCM
- 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 requiring general anesthesia 30 days prior to screening or during the study period
- AST of ALT greater than 1.5 times the upper limit of normal
- Received an investigational drug within 30 days of screening
- Pregnant or sexually-active females who are not able to use an effective form of birth control
Sites / Locations
- Luitpold Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferric Carboxymaltose (FCM)
Standard Medical Care
Arm Description
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Per product label
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00704353
Brief Title
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
Official Title
A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of a Single Dose of Intravenous Ferric Carboxymaltose (FCM) vs. Standard Medical Care in Treating Iron Deficiency Anemia in Subjects Who Are Not Dialysis Dependent
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
735 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Arm Title
Standard Medical Care
Arm Type
Active Comparator
Arm Description
Per product label
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose
Intervention Description
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Intervention Type
Drug
Intervention Name(s)
Standard Medical Care (SMC)
Other Intervention Name(s)
Ferrous Sulfate, Venofer, Ferrlecit, Infed, Dexferrum
Intervention Description
Per product label
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
Time Frame
through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects ≥18 years of age and able to give informed consent
Iron deficiency is the primary etiology of anemia
Screening Visit central laboratory Hgb indicative of anemia ≤12 g/dL
Screening Visit ferritin indicative of iron deficiency anemia ≤100 ng/mL or ≤300 when TSAT was ≤30%
Exclusion Criteria:
Previous participation in a FCM trial
Known hypersensitivity reaction to FCM
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 requiring general anesthesia 30 days prior to screening or during the study period
AST of ALT greater than 1.5 times the upper limit of normal
Received an investigational drug within 30 days of screening
Pregnant or sexually-active females who are not able to use an effective form of birth control
Facility Information:
Facility Name
Luitpold Pharmaceuticals
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
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