Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

American Regent, Inc.145 enrolled

Overview

The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

145

Conditions

Anemia

Interventions

Ferric Carboxymaltose (FCM)DRUG

maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who completed or discontinued Protocol 1VIT04004 Exclusion Criteria: * Known hypersensitivity reaction to VIT-45 * Anemia not related to CKD * Chronic, serious infection * Recent IV iron other than study drug in past 12 weeks * Recent blood loss within the last 12 weeks * Need for surgery or dialysis * Female subjects who are pregnant or lactating

Locations (1)

Luitpold Pharmaceuticals Inc.

Norristown, Pennsylvania, United States

Outcomes

Primary Outcomes

Incidence of Treatment-emergent Adverse Events

Time frame: 44 week study duration

Data from ClinicalTrials.gov

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