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 |
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.
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
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