Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
CompletedPhase 3Results postedLast updated 21 March 2022
What this trial tests
Phase 3 trial testing Ferric carboxymaltose in Iron Deficiency Anemia in 7 participants. Completed in 29 January 2021.
Adults 1 to 18, any sex, with Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Hemoglobin From Baseline to Day 35Primary· The change in Hgb from baseline to day 35
The change in hemoglobin from Baseline to Day 35 was assessed using paired t-tests (two-sided test, α = 0.05). Baseline hemoglobin was defined as the last hemoglobin obtained before the first dose.
Group
Value
95% CI
IV Iron
0.70
-0.40 – 1.80
Sponsor's own description
Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol 1VIT17044
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07057973 — The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly
· NA
· recruiting
NCT05744219 — Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial
· Phase 3
· recruiting
NCT06080893 — The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures
· Phase 4
· completed
NCT05545527 — Neuroimaging Ancillary Study
· completed
NCT04968379 — Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
· Phase 2
· withdrawn
Other recruiting trials for Iron Deficiency Anemia
Currently open trials in the same condition.
NCT07483645 — Effectiveness and Acceptability of LISEFEX® (Liposomal Iron With Vitamin C and Fiber) in People With Iron Deficiency Ane
· active not recruiting
NCT06012760 — The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
· NA
· recruiting
NCT06742528 — Comparison Of Efficacy Of Iron Polymaltose Complex And Ferrous Sulphate In Iron Deficiency Anemia In Pediatric Patients
· NA
· recruiting
NCT05929729 — Iron Deficiency Anemia (IDA) and the Brain
· Phase 4
· recruiting
NCT05985070 — Evaluating the Effectiveness of Various Iron Salts in Oral Iron Therapy for Iron Deficiency and Anemia in Healthy Adults
· NA
· active not recruiting
Other American Regent, Inc. trials
Trials by the same sponsor.
NCT05661682 — Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety
· Phase 4
· withdrawn
NCT04968379 — Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
· Phase 2
· withdrawn
NCT03523117 — Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
· Phase 3
· completed
NCT02826681 — Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
· Phase 2
· terminated
NCT03037931 — Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by American Regent, Inc.
Last refreshed: 21 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04269707.