Prospective, Monocentric, Open-label, Randomized Study Comparing Intradialytic Plasma Kinetics of Amino Acids After Administration Per os of Renoral® and Intravenous Administration of Amino Acids.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Plasma total amino acid concentration
研究概览
简要总结
The aim of the study is to compare intradialytic plasma kinetics of amino acids after administration per os of Renoral or intravenous administration of amino acids in patients with end-stage renal disease treated with hemodialysis maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over 18 (limit included),
- •Patients treated with hemodialysis for at least 3 months (limit included),
- •Patient with normal albuminemia ≥ 35 g/L
- •Patient capable and willing to comply with the protocol and willing to give written informed consent,
- •Patient affiliated to a social security scheme.
排除标准
- •Patient with a known food allergy or intolerance,
- •Patient with alcohol consumption ≥ 20 g/day (equivalent to 2 glasses per day),
- •Patient following a specific diet (vegetarian, hypocaloric, restrictive gluten-free diet....) outside the high-protein diet of the patient with terminal renal insufficiency or deviant behavior,
- •Pregnant or breastfeeding woman or intending to become pregnant within the next 3 months
- •Patient taking vitamin or mineral supplementation for less than one month,
- •Patient participating in another clinical study or in a period of exclusion from a previous clinical study;
- •Patient refusing to give written consent,
- •Patient not able to read and understand information, consent or other study related documents (self-administered questionnaires),
- •Patient unable to give informed consent,
- •Patient deprived of liberty by administrative or judicial decision, under guardianship or curatorship.
研究组 & 干预措施
AMINOVEN® 10%
The AMINOVEN® 10% comparative product is a drug in the form of a 130 mL intravenous infusion solution. This product is composed of amino acids.
The product is administered per os during the first hour of dialysis sessions for the duration of the study.
干预措施: Aminoven 10% (Drug)
RENORAL®
The product under study RENORAL® is notified to the DGCCRF with the status of food supplement for medical purposes (FSMP) and specific for renal insufficiency.
The product is a beverage packaged in 150 mL aluminum cans. It contains a liquid solution of native milk proteins and partially hydrolyzed whey proteins.
干预措施: RENORAL (Dietary Supplement)
结局指标
主要结局
Plasma total amino acid concentration
时间窗: Day 60; Time 240 minutes of the kinetic
The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.
次要结局
- Inflammation degree(Day 90; Day 120 and Day 150 at time 0 minutes of kinetics)
- Protein catabolism(Day 90; Day 120 and Day 150 at time 0 minutes of kinetics)
- Plasma total amino acid concentration(Day 90; Day 120 and Day 150 at time 240 minutes of kinetics)
- Acceptability of Renoral®(Day 60 and Day 150)
- Nutritional status(During the week preceding Day 150)
- Muscular force(Day 150)