VIT45 Versus Oral Iron in the Treatment… | Clinical Trial

Key information

Conditions

Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulfate tablets

Drug

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.

Primary outcomes

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

Time frame: anytime during the study

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Apr 24, 2006
Registry last updated: Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed