Ferric carboxymaltose vs Ferric derisomaltose

NCT03037931 · Phase 3 · completed

The trial was randomized, double-blind, placebo-controlled, and large, with 1,532 participants assigned to ferric carboxymaltose and 1,533 to placebo. Its clinical primary endpoints showed numerically favorable results for ferric carboxymaltose, but the registry does not state whether the primary comparisons were statistically significant, so the findings remain unclear.

NCT00537186 · Phase 3 · completed

Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

NCT00317239 · Phase 3 · completed

The study randomized 255 participants to ferric carboxymaltose or active oral iron treatment, but it was open-label rather than blinded. Its primary endpoint was a surrogate hemoglobin response measure, and although the reported counts favored ferric carboxymaltose, statistical significance is not reported, so the result cannot be considered definitively met.

NCT02940860 · Phase 3 · completed

This was a large (n=1538), randomized, open-label, active-controlled Phase 3 trial of ferric derisomaltose versus iron sucrose in non-dialysis-dependent chronic kidney disease with iron deficiency anemia. The primary efficacy endpoint — change in hemoglobin from baseline to week 8 — met its prespecified non-inferiority margin (difference 0.08 g/dL; 95% CI -0.06 to 0.23, lower bound above -0.5 g/dL), and the co-primary safety endpoint of serious or severe hypersensitivity reactions was low in the ferric derisomaltose arm (3/1019, 95% CI upper bound 0.86%, below the 3% threshold). Although the trial was adequately powered with a hard clinical endpoint, it was open-label rather than double-blind, which is a meaningful design limitation.