NCT00317239View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

February 28, 2007

Study Completion Date

August 31, 2007

Conditions
Anemia
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.

Trial Locations (1)

19403

Luitpold Pharmaceuticals, Norristown

Sponsors
All Listed Sponsors
lead

American Regent, Inc.

INDUSTRY