Chronic Kidney Disease Clinical Trial
Official title:
An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease
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).
After an initial screening period of up to 4 weeks, eligible subjects were randomised
(1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.
1. FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin
level of 400-600 mcg/L.
2. FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin
level of 100-200 mcg/L.
3. Daily oral iron with 200 mg iron/day (100 mg twice daily)
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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