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

Indigo Therapeutics

Status: Unknown

Conditions: End Stage Renal Disease on Dialysis (Diagnosis)

Treatments: Drug: Aminoven 10%; Dietary Supplement: RENORAL

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03807583

ID-RCB 2018-00145-50

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Control group

No Intervention group

AMINOVEN® 10%

Active Comparator group

Description:

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.

Treatment:

Drug: Aminoven 10%

RENORAL®

Experimental group

Description:

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.

Treatment:

Dietary Supplement: RENORAL