Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
NCT ID: NCT00317226
Last Updated: 2018-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
145 participants
INTERVENTIONAL
2005-06-30
2007-09-30
Brief Summary
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Detailed Description
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In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ferric Carboxymaltose (FCM)
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Ferric Carboxymaltose (FCM)
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Interventions
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Ferric Carboxymaltose (FCM)
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Anemia not related to CKD
* Chronic, serious infection
* Recent IV iron other than study drug in past 12 weeks
* Recent blood loss within the last 12 weeks
* Need for surgery or dialysis
* Female subjects who are pregnant or lactating
12 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 Inc.
Norristown, Pennsylvania, United States
Countries
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Other Identifiers
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1VIT05005
Identifier Type: -
Identifier Source: org_study_id
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