CompletedPhase 3

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

United States255 participantsStarted 2005-05

Plain-language summary

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).

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males or females \> or = 12 years of age * NDD-CKD subjects * Baseline hemoglobin \< or = 11g/dl * Stable erythropoietin (EPO) status Exclusion Criteria: * 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

What they're measuring

Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL

Timeframe: anytime during the study

Trial details

NCT IDNCT00317239

SponsorAmerican Regent, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-02

Results submitted2013-09-16

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