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

NCT00317239 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2018-02-20

Study results available
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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).

Conditions

Interventions

DRUG

Ferrous Sulfate tablets

325 mg/TID x 8 weeks

DRUG

Ferric Carboxymaltose (FCM)

A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-02-28
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00317239 on ClinicalTrials.gov