NCT06350955
Recruiting
Phase 4
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®)
Lucie Favre1 site in 1 country94 target enrollmentStarted: May 2, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Lucie Favre
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- incidence of hypophosphatemia in RYGB patients treated with intravenous iron
Overview
Brief 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®).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with Roux-en-Y gastric bypass and iron deficiency 1
Experimental
Intervention: Iron isomaltoside (Drug)
Patients with Roux-en-Y gastric bypass and iron deficiency 2
Experimental
Intervention: Iron Carboxymaltose (Drug)
Outcomes
Primary Outcomes
incidence of hypophosphatemia in RYGB patients treated with intravenous iron
Time Frame: day 14 ± 2, 21 ± 2 and 28 ± 2
Secondary Outcomes
No secondary outcomes reported
Investigators
Lucie Favre
Co-director of the Obesity Center, CHUV
Centre Hospitalier Universitaire Vaudois
Study Sites (1)
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