IV Iron-induced Hypophosphatemia After RYGB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iron isomaltoside, Iron Carboxymaltose.
- Who it may be relevant to
- Registry conditions: Hypophosphatemia, Roux-en-Y Gastric Bypass. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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®)
Overview
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®).
Interventions
- Drug Iron isomaltoside
single dose of 500 mg iron isomaltoside - Drug Iron Carboxymaltose
single dose of 500 mg ferric carboxymaltose
Primary outcome measures
- incidence of hypophosphatemia in RYGB patients treated with intravenous iron [Time frame: day 14 ± 2, 21 ± 2 and 28 ± 2]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- CHUV — Lausanne
Identifiers
NCT: NCT06350955 · 2022-01389