IV Iron-induced Hypophosphatemia After RYGB

Roux-en-Y Gastric Bypass Clinical Trial

— IVORY  

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®)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350955
• Other study ID #: 2022-01389
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypophosphatemia
• Roux-en-Y Gastric Bypass

Intervention

Drug:
• Iron isomaltoside
single dose of 500 mg iron isomaltoside
• Iron Carboxymaltose
single dose of 500 mg ferric carboxymaltose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lucie Favre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of hypophosphatemia in RYGB patients treated with intravenous iron		day 14 ± 2, 21 ± 2 and 28 ± 2