Conditions: Iron Deficiency Anaemia Chronic Kidney Disease
Keywords: Ferinject Iron Deficiency Anaemia Chronic Kidney Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 626
Healthy volunteers: no

Brief 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).

Detailed description:
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)

Arms:
arm 1: Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L arm 2: Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L arm 3: Ferrous sulphate 100 mg iron twice daily, continuous

Interventions: intervention 1: FCM (Ferric carboxymaltose) high ferritin target intervention 2: FCM (Ferric carboxymaltose) low ferritin target intervention 3: Oral Iron (Ferrous sulphate)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: