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

Completed · Phase 2

Conditions studied: Anemia

In brief

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

Key facts

Study ID

NCT00721188

Run by

American Regent, Inc.

People needed

11

Starts

2006-01-01

Expected to finish

2010-01-01

Last updated by the study team

2018-02-20

Who can join

Age: 12 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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