IV Iron-induced Hypophosphatemia After RYGB (IVORY)

Lucie Favre

Status and phase

Enrolling

Phase 4

Conditions

Hypophosphatemia

Roux-en-Y Gastric Bypass

Treatments

Drug: Iron Carboxymaltose

Drug: Iron isomaltoside

Study type

Interventional

Funder types

Other

Identifiers

NCT06350955

2022-01389

Details and patient eligibility

About

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®).

Enrollment

94 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.