Status:
COMPLETED
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
Lead Sponsor:
American Regent, Inc.
Conditions:
Anemia
Eligibility:
All Genders
12-16 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
Eligibility Criteria
Inclusion
- Age \> or = 12 to \< or = 16 years
- 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
- Known history of hypersensitivity to any component of Venofer
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00721188
Start Date
January 1 2006
End Date
January 1 2010
Last Update
February 20 2018
Active Locations (1)
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1
Luitpold Pharmaceuticals
Norristown, Pennsylvania, United States, 19403