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

American Regent, Inc.255 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

255

Conditions

Anemia

Interventions

Ferrous Sulfate tabletsDRUG

325 mg/TID x 8 weeks

Ferric Carboxymaltose (FCM)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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: anytime during the study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.