IV Iron-induced Hypophosphatemia After RYGB

NCT06350955 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2022-01389
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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®).

Conditions

Hypophosphatemia; Roux-en-Y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• incidence of hypophosphatemia in RYGB patients treated with intravenous iron

  day 14 ± 2, 21 ± 2 and 28 ± 2

Study Arms (2)

Patients with Roux-en-Y gastric bypass and iron deficiency 1

EXPERIMENTAL

Drug: Iron isomaltoside

Patients with Roux-en-Y gastric bypass and iron deficiency 2

EXPERIMENTAL

Drug: Iron Carboxymaltose

Interventions

Iron isomaltoside DRUG

single dose of 500 mg iron isomaltoside

Patients with Roux-en-Y gastric bypass and iron deficiency 1

Iron Carboxymaltose DRUG

single dose of 500 mg ferric carboxymaltose

Patients with Roux-en-Y gastric bypass and iron deficiency 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Lucie Favre: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1003, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypophosphatemia

Interventions

iron isomaltoside 1000; ferric carboxymaltose

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-director of the Obesity Center, CHUV

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 8, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

CH (1)