Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency Anemia
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
1 other identifier
interventional
735
1 country
1
Brief Summary
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
November 25, 2013
CompletedFebruary 20, 2018
January 1, 2018
1.1 years
June 20, 2008
September 16, 2013
January 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Serious Adverse Events (SAE's)
through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA)
Study Arms (2)
Ferric Carboxymaltose (FCM)
EXPERIMENTAL15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Standard Medical Care
ACTIVE COMPARATORPer product label
Interventions
15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0.
Per product label
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Luitpold Pharmaceuticals
Norristown, Pennsylvania, 19403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Falone, MD
- Organization
- Luitpold Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 24, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2009
Study Completion
March 1, 2011
Last Updated
February 20, 2018
Results First Posted
November 25, 2013
Record last verified: 2018-01