NCT06350955 IV Iron-induced Hypophosphatemia After RYGB
| NCT ID | NCT06350955 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lucie Favre |
| Condition | Hypophosphatemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2024-05-02 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 94 participants in total. It began in 2024-05-02 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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®).
Eligibility Criteria
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 daily multivitamin preparation recommended after bariatric surgery; the exact amount of phosphate and iron supplementation in the daily multivitamin will be recorded) * Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen receptor modulators). * Patient who refuses to be informed of incidental discoveries that may contribute to the prevention, diagnosis, and treatment of existing or probable future illnesses.
Frequently Asked Questions
Who can join the NCT06350955 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Hypophosphatemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06350955 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06350955 currently recruiting?
Yes, NCT06350955 is actively recruiting participants. Visit ClinicalTrials.gov or contact Lucie Favre to inquire about joining.
Where is the NCT06350955 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06350955 clinical trial?
NCT06350955 is sponsored by Lucie Favre. The trial plans to enroll 94 participants.