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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferric Carboxymaltose (FCM); Drug: Ferrous Sulfate tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00317239

1VIT04004

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 255 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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255 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

Description:

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.

Treatment:

Drug: Ferric Carboxymaltose (FCM)

Ferrous Sulfate tablets

Active Comparator group

Description:

325 mg/TID x 8 weeks

Treatment:

Drug: Ferrous Sulfate tablets