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drugset / Trial / NCT00317226

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

NCT00317226 ↗

Phase 3 Completed 145 enrolled American Regent, Inc.
NaSingle-groupOpen-labelTreatment

Summary

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).

Timeline

Start
2005-06
Primary completion
2007-03
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 1000 mg Intravenous

Indications

anemia