VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Completed · Phase 3

Conditions studied: Anemia

In brief

This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).

Key facts

Study ID

NCT00317239

Run by

American Regent, Inc.

People needed

255

Starts

2005-05-01

Expected to finish

2007-08-01

Last updated by the study team

2018-02-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females > or = 12 years of age
• NDD-CKD subjects
• Baseline hemoglobin < or = 11g/dl
• Stable erythropoietin (EPO) status

You may not qualify if…

• Known hypersensitivity to ferrous sulfate or IV iron
• Unstable EPO status
• Anemia not related to CKD
• Chronic, serious infection
• Recent IV iron
• Recent blood transfusion
• Recent blood loss
• Need for surgery
• Received investigational drug within 30 days
• Female subjects who are pregnant or lactating

Where it is running

• Luitpold Pharmaceuticals — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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