Title
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
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.
Phase
N/ALead Sponsor
Indigo TherapeuticsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
End Stage Renal Disease on Dialysis (Diagnosis)Intervention/Treatment
Aminoven 10% RENORALStudy Participants
30The 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.
After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group: group A: RENORAL® product group B: AMINOVEN® 10% product group C: control group (without intradialytic supplementation) Patients will consume the products and will be followed for 3 months, one visit per month (Day 90, Day 120, Day 150). Protocol visits are included in the patient's course of care.
After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group: group A: RENORAL® product group B: AMINOVEN® 10% product group C: control group (without intradialytic supplementation) Patients will consume the products and will be followed for 3 months, one visit per month ( V3, V4, V5). Protocol visits are included in the patient's course of care.
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.
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.
Inclusion Criteria: 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. Exclusion Criteria: 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.
