Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia

Summary

This is a confirmatory trial to establish superior serum phosphate stability associated with use of Phoscap® compared with placebo as a supplement for treatment of iron deficiency or iron deficiency anemia with Ferinject® before elective surgery.

Timeline

Start

2021-11-11

Primary completion

2023-05-09

Completion

2023-05-23

Outcome

Missed primary endpoint

paper 0.49 ± 0.21 mmol/L in the treatment group and 0.42 ± 0.17 mmol/L in the placebo group (p = 0.12, two-sided p-value). PMID 39671753 ↗

Publications

• Results Munoz M, Gomez-Ramirez S, Campos A, Ruiz J, Liumbruno GM. Pre-operative anaemia: prevalence, consequences and approaches to management. Blood Transfus. 2015 Jul;13(3):370-9. doi: 10.2450/2015.0014-15. Epub 2015 Jun 16. No abstract available.
• Results Munoz M, Laso-Morales MJ, Gomez-Ramirez S, Cadellas M, Nunez-Matas MJ, Garcia-Erce JA. Pre-operative haemoglobin levels and iron status in a large multicentre cohort of patients undergoing major elective surgery. Anaesthesia. 2017 Jul;72(7):826-834. doi: 10.1111/anae.13840. Epub 2017 Apr 6.
• Results Wolf M, Koch TA, Bregman DB. Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women. J Bone Miner Res. 2013 Aug;28(8):1793-803. doi: 10.1002/jbmr.1923.
• Kaserer A, Braun J, Mair A, Akbas S, Rossler J, Bischoff-Ferrari HA, Turina M, Clavien PA, Opitz I, Hulsmeier A, Karsai G, Gasciauskaite G, Spahn GH, Schlapfer M, Spahn DR. Ferric carboxymaltose with or without phosphate substitution in iron deficiency or iron deficiency anemia before elective surgery - The DeFICIT trial. J Clin Anesth. 2025 Feb;101:111727. doi: 10.1016/j.jclinane.2024.111727. Epub 2024 Dec 12.

Drugs

Indications