Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
NCT ID: NCT00721188
Last Updated: 2018-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2006-01-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pharmacokinetic Population
All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.
Venofer
Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.
Interventions
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Venofer
Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.
Eligibility Criteria
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Inclusion Criteria
* Parent and/or legal guardian able to give informed consent
* Subject able to give written assent for participating in the study
* NDD-CKD defined as: kidney damage for 3 months or longer, or GFR \< 60 for 3 months or longer
* Hemoglobin indicative of anemia
* Ferritin indicative of iron deficiency anemia
* If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period
Exclusion Criteria
* Parenteral iron within 14 days of the screening visit
* Dialysis dependent-CKD
* Chronic or serious active infection
* Pregnancy or lactation
* Subjects with causes of iron deficiency anemia other than CKD
* Blood transfusion within the last month or anticipated during the study
* Body weight \< 55 pounds
* Received an investigational drug within 30 days before screening
12 Years
16 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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1VEN05033
Identifier Type: -
Identifier Source: org_study_id
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