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

Indigo Therapeutics30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease on Dialysis (Diagnosis)

Interventions

Aminoven 10%DRUG

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.

RENORALDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hopital Center

Dunkirk, France

RECRUITING

Outcomes

Primary Outcomes

Plasma total amino acid concentration

The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.

Time frame: Day 60; Time 240 minutes of the kinetic

Secondary Outcomes

Plasma total amino acid concentration

Comparison between the RENORAL® group and the plasma total amino acid concentration control group

Time frame: Day 60; Time 240 minutes of kinetics

Plasma total amino acid concentration

Comparison between the RENORAL® group and each AMINOVEN® group and control

Time frame: Time 0 minutes, Time 60 minutes and Time 120 minutes of kinetics

Plasma total amino acid concentration

Comparison between the RENORAL® group and each AMINOVEN® group and control

Time frame: Day 90; Day 120 and Day 150 at time 240 minutes of kinetics

Protein catabolism

Plasma urea concentration (mmol.L-1) ;

Time frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics

Protein catabolism

Plasma creatinine concentration (µmol.L-1);

Time frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics

Protein catabolism

Standardized protein catabolism rate (nPCR) (g/kg/day): * BUN: Blood urea nitrogen is one of the main renal function parameters (mmol/L). * ID Refers to the interdialytic period in hours. * ID BUN rise refers to the registered change in blood urea nitrogen during the interdialytic period. The two nPCR formulas used are: nPCR Anuric = 0.22 + (0.864 x (ID BUN rise in mg/dL) / (ID hours)) nPCR Total = nPCR Anuric + (Urine urea nitrogen in g x 150) / (ID hours x Weight in kg)

Central Contacts

RAYMOND AZAR, MD

CONTACT

+333 28 28 53 28 Raymond.Azar@ch-dunkerque.fr

FAHIMA YAHI

CONTACT

+333 28 28 59 00 Fahima.Yahi-Zidat@ch-dunkerque.fr

Data from ClinicalTrials.gov

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