Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (FIND-CKD)
|Iron Deficiency Anaemia Chronic Kidney Disease||Drug: FCM (Ferric carboxymaltose) high ferritin target Drug: FCM (Ferric carboxymaltose) low ferritin target Drug: Oral Iron (Ferrous sulphate)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger [ Time Frame: Up to 1 year after baseline ]
Endpoint reported number of participants with/without events and was reached:
- First time of initiation of additional or alternative anaemia management,
First time the subject reached the Hb trigger.
3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:
- FCM (high ferritin target) compared with oral iron.
- FCM (high ferritin target) compared with FCM (low ferritin target).
- FCM (low ferritin target) compared with oral iron.
Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:
- Without taking into account the Hb trigger.
- Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.
- Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory.
|Study Start Date:||December 2009|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: FCM (high ferritin target)
Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
Drug: FCM (Ferric carboxymaltose) high ferritin target
Experimental: FCM (low ferritin target)
Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
Drug: FCM (Ferric carboxymaltose) low ferritin target
Active Comparator: Oral Iron
Ferrous sulphate 100 mg iron twice daily, continuous
Drug: Oral Iron (Ferrous sulphate)
Other Name: Ferrous sulphate
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.
- FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L.
- FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L.
- Daily oral iron with 200 mg iron/day (100 mg twice daily)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994318
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|Principal Investigator:||Iain Macdougall||King's College Hospital NHS Trust|