Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard Medical Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
1 other identifier
interventional
513
1 country
1
Brief Summary
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2007
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
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 22, 2007
CompletedFirst Posted
Study publicly available on registry
October 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
May 13, 2015
CompletedFebruary 20, 2018
January 1, 2018
1.3 years
October 22, 2007
September 16, 2013
January 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-emergent Serious Adverse Events (SAE's)
from Day 0 through 30 days after the last dose of study drug
Study Arms (2)
Ferric Carboxymaltose (FCM)
EXPERIMENTALSubjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
Standard Medical Care (SMC)
ACTIVE COMPARATORSMC for IDA (as determined by the Investigator) for treating CKD related anemia.
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female 18 to 85 years of age
- NDD-CKD Patients
- TSAT \</= 25%
- Hgb \</= 11.5
- Ferritin \</= 300
- HD-CKD Patients
- TSAT \</= 30%
- Hgb \</= 12
- Ferritin \</= 500
You may not qualify if:
- Previous participation in a FCM trial
- Known Hypersensitivity to FCM
- History of anemia other that anemia due to chronic renal failure
- Current history of GI bleeding
- Received IV Iron within the last 30 Days
- Anticipated need for surgery
- Malignancy history
- AST or ALT greater than normal
- Received an investigational drug within 30 days of screening
- Pregnant or sexually active females who are not willing 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)
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
October 22, 2007
First Posted
October 24, 2007
Study Start
October 1, 2007
Primary Completion
January 1, 2009
Study Completion
July 1, 2009
Last Updated
February 20, 2018
Results First Posted
May 13, 2015
Record last verified: 2018-01