Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indigo Therapeutics
• Collaborator: BioFortis

Criteria

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.