IV Iron-induced Hypophosphatemia After RYGB (IVORY)

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®)

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®).

Study Overview

• Status: Recruiting
• Conditions: Roux-en-Y Gastric Bypass; Hypophosphatemia
• Intervention / Treatment: Drug: Iron isomaltoside; Drug: Iron Carboxymaltose

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1003
      • Recruiting
      • CHUV
      • Contact: Lucie Favre, MD; Phone Number: +41 21 3140548; Email: lucie.favre@chuv.ch
      • Contact: Sara Santini, MD; Email: sara.santini@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Roux-en-Y gastric bypass and iron deficiency 1	Drug: Iron isomaltoside; single dose of 500 mg iron isomaltoside
Experimental: Patients with Roux-en-Y gastric bypass and iron deficiency 2	Drug: Iron Carboxymaltose; single dose of 500 mg ferric carboxymaltose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of hypophosphatemia in RYGB patients treated with intravenous iron	day 14 ± 2, 21 ± 2 and 28 ± 2

Collaborators and Investigators

• Sponsor: Lucie Favre

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hypophosphatemia; Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Iron isomaltoside 1000; Iron
• Other Study ID Numbers: 2022-01389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes