IV Iron-induced Hypophosphatemia After RYGB (NCT06350955) | Clinical Trial Compass
RecruitingPhase 4
IV Iron-induced Hypophosphatemia After RYGB
Switzerland94 participantsStarted 2024-05-02
Plain-language summary
The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients over 18 years
* Signed informed consent
* Patients with previous RYGB surgery performed \> 12 months ago
* Failed response to oral iron supplementation
* Established diagnosis of iron deficiency by ferritin \< 50 ug/l or serum ferritin ≤100ug/l and low transferrin saturation (TSAT) ≤ 30%
* Normal phosphate blood level (0.8 - 1.45 mmol/l) before infusion
* Normal magnesium blood level (0.65-1.05 mmol/l)
* Outpatient
Exclusion Criteria:
* \- Patients with known hypersensitivity to iron preparation and/or anaphylaxis from any cause
* Patients for whom a treatment with one of the IV iron is contra-indicated (based on product summary of product characteristics)
* Women who are pregnant or breastfeeding
* Intention to become pregnant during the course of the study
* Renal failure, chronic kidney disease stage 3b or worse (eGFR ≤ 45 ml/min/1.73m2)
* Patients who received IV iron infusion during the last 3 months before screening
* Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion within the last 3 months prior to screening
* Alcohol or drug abuse within the past 6 months
* Planned surgical procedure within the clinical trial period
* Surgery under general anaesthesia within the last 3 months prior to screening
* Hyperparathyroidism
* Kidney transplantation
* Inability to follow study procedures or give informed consent
* Use and inability to stop from V0 to study end, phosphate supplementation (except dai…
What they're measuring
1
incidence of hypophosphatemia in RYGB patients treated with intravenous iron