drugset / Trial / NCT00994318

Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

NCT00994318

RandomizedParallel-groupOpen-labelTreatment

Summary

Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).

Timeline

Start
2009-12
Primary completion
2013-02
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 200 mg Intravenous
Subject Ferric carboxymaltose Other / unclassified 1000 mg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 100 mg Oral