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New treatment option for Hypophosphatemia
Official title IV Iron-induced Hypophosphatemia After RYGB
ClinicalTrials.gov ID: NCT06350955
What this study is testing
What is Iron isomaltoside?
Iron isomaltoside is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hypophosphatemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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®).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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%
You likely can't join if
- \- 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
See the full eligibility 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
- \- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.