Comparing IV Iron Treatments for Patients After Gastric Bypass
Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric Carboxymaltose (Ferinject®)
This study is testing whether two different types of IV iron treatments can help people who have had gastric bypass surgery and still have low iron levels after trying oral iron supplements.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Lausanne, Canton of Vaud) |
| Trial ID | NCT06350955 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the incidence of hypophosphatemia in patients who have undergone Roux-en-Y gastric bypass (RYGB) and are treated with either iron isomaltoside or ferric carboxymaltose. It focuses on patients who have not responded to oral iron supplementation and have specific iron deficiency criteria. The study will involve administering a single intravenous dose of one of the iron preparations and monitoring phosphate levels post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have had RYGB surgery more than 12 months ago and have not responded to oral iron supplements.
Not a fit: Patients with known hypersensitivity to iron preparations or those with severe renal failure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for iron deficiency in RYGB patients, potentially improving their overall health and quality of life.
How similar studies have performed: Other studies have explored IV iron treatments, but this specific comparison in RYGB patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lausanne, Canton of Vaud
- Chuv — Lausanne, Canton of Vaud, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.