Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - 16
Updated:2/22/2018
Start Date:January 2006
End Date:January 2010

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Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron
Sucrose Injection) in NDD-CKD pediatric patients.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
Norristown, Pennsylvania 19403
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Norristown, PA
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