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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.