Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
NCT ID: NCT00548691
Last Updated: 2018-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
513 participants
INTERVENTIONAL
2007-10-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ferric Carboxymaltose (FCM)
Subjects 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.
Ferric Carboxymaltose
Standard Medical Care (SMC)
SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
Standard Medical Care (SMC)
Interventions
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Ferric Carboxymaltose
Standard Medical Care (SMC)
Eligibility Criteria
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Inclusion Criteria
* NDD-CKD Patients
* TSAT \</= 25%
* Hgb \</= 11.5
* Ferritin \</= 300
* HD-CKD Patients
* TSAT \</= 30%
* Hgb \</= 12
* Ferritin \</= 500
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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American Regent, Inc.
INDUSTRY
Responsible Party
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Locations
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Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States
Countries
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Other Identifiers
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1VIT07018
Identifier Type: -
Identifier Source: org_study_id
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