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NCT Number: NCT06350955

IV Iron-induced Hypophosphatemia After RYGB

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®).

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron isomaltoside

Drug

single dose of 500 mg iron isomaltoside

Iron Carboxymaltose

Drug

single dose of 500 mg ferric carboxymaltose

Primary outcomes

  1. incidence of hypophosphatemia in RYGB patients treated with intravenous iron

    Time frame: day 14 ± 2, 21 ± 2 and 28 ± 2

Sponsors and collaborators

Lead sponsor

Lucie Favre

Other

Registry information

Official study 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®)

Acronym: IVORY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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