NCT06350955招募中4 期
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 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年5月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- incidence of hypophosphatemia in RYGB patients treated with intravenous iron
研究概览
简要总结
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®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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.
研究组 & 干预措施
Patients with Roux-en-Y gastric bypass and iron deficiency 1
Experimental
干预措施: Iron isomaltoside (Drug)
Patients with Roux-en-Y gastric bypass and iron deficiency 2
Experimental
干预措施: Iron Carboxymaltose (Drug)
结局指标
主要结局
incidence of hypophosphatemia in RYGB patients treated with intravenous iron
时间窗: day 14 ± 2, 21 ± 2 and 28 ± 2
次要结局
未报告次要终点
研究者
Lucie Favre
Co-director of the Obesity Center, CHUV
Centre Hospitalier Universitaire Vaudois
研究点 (1)
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