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

Completed · Phase 3

Conditions studied: Anemia

In brief

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).

Key facts

Study ID

NCT00317226

Run by

American Regent, Inc.

People needed

145

Starts

2005-06-01

Expected to finish

2007-09-01

Last updated by the study team

2018-02-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who completed or discontinued Protocol 1VIT04004

You may not qualify if…

• 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

Where it is running

• Luitpold Pharmaceuticals Inc. — Norristown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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