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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-08-31

Brief Summary

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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).

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Detailed Description

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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

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ferric Carboxymaltose (FCM)

Intervention Type DRUG

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.

Ferrous Sulfate tablets

325 mg/TID x 8 weeks

Group Type ACTIVE_COMPARATOR

Ferrous Sulfate tablets

Intervention Type DRUG

325 mg/TID x 8 weeks

Interventions

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Ferrous Sulfate tablets

325 mg/TID x 8 weeks

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No