Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency… (NCT05098249) | Clinical Trial Compass
CompletedPhase 4
Ferric Carboxymaltose With or Without Phosphate Substitution for the Treatment of Iron Deficiency or Iron Deficiency Anemia
Switzerland92 participantsStarted 2021-11-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Informed Consent as documented by signature (Appendix 5: Informed Consent Form)
* Male or female ASA 1 to 3 patients, at least 18 years old
* Scheduled for an elective major abdominal or thoracic surgery.
* Patients with isolated iron deficiency (defined as hemoglobin concentration (Hb) \> 130 g/l, and plasma Ferritin \< 100 ng/ml or TSAT \< 20%), or iron deficiency anemia (defined as Hb 100-130 g/l, and plasma Ferritin \< 100 ng/ml or TSAT \< 20%).
* Patients scheduled to be hospitalized ≥ 3 days.
Exclusion Criteria:
* Patients with known anaphylactic reactions to parenteral iron products. Patients with allergy/hypersensitivity to any contents of Ferinject® or Phoscap®.
* Patients with iron overload or disturbances in utilization of iron (e.g. haemochromatosis, hemosiderosis).
* Patients with ≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range.
* Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood cell units).
* Patients with known myelodysplastic syndromes.
* Patients with chronic kidney disease with an estimated GFR \< 30 ml/min or with end-stage renal disease requiring scheduled dialysis.
* Patients with known urinary tract infections with urea-splitting bacteria.
* Patients with known diseases influencing phosphate, calcium or vitamin D homeostasis (e.g. Hyperparathyroidism, X-linked hypophosphatemia, renal tubular acidosis).
* Patients taking medication significantl…