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.

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 Overview

• Status: Unknown
• Conditions: End Stage Renal Disease on Dialysis (Diagnosis)
• Intervention / Treatment: Drug: Aminoven 10%; Dietary supplement: RENORAL

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: RAYMOND AZAR, MD; Phone Number: +333 28 28 53 28; Email: Raymond.Azar@ch-dunkerque.fr
• Study Contact Backup: Name: FAHIMA YAHI; Phone Number: 6486 +333 28 28 59 00; Email: Fahima.Yahi-Zidat@ch-dunkerque.fr

Study Locations

• France
  • Dunkerque, France, 59240
    • Recruiting
    • Hopital Center
    • Contact: FAHIMA YAHI; Phone Number: 6486 +333 28 28 59 00; Email: Fahima.Yahi-Zidat@ch-dunkerque.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Active Comparator: 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.	Drug: Aminoven 10%; 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.
Experimental: 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.	Dietary supplement: RENORAL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma total amino acid concentration	The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.	Day 60; Time 240 minutes of the kinetic

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma total amino acid concentration	Comparison between the RENORAL® group and the plasma total amino acid concentration control group	Day 60; Time 240 minutes of kinetics
Plasma total amino acid concentration	Comparison between the RENORAL® group and each AMINOVEN® group and control	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	Day 90; Day 120 and Day 150 at time 240 minutes of kinetics
Protein catabolism	Plasma urea concentration (mmol.L-1) ;	Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Protein catabolism	Plasma creatinine concentration (µmol.L-1);	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)	Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Inflammation degree	Comparison between the RENORAL® group and each AMINOVEN® group and control. Evaluated by plasma CRPus concentration (mg.L-1).	Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Nutritional status	Plasma albumin concentration (g.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status	- Plasma prealbumin concentration (g.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status	- Plasma ferritin concentration (µg.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status	- Plasma transferrin concentration (ng.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Nutritional status	- Body mass index (BMI) (kg/m2)	Day 150
Nutritional status	- Body composition by impedance measurement (Body Composition Monitor / Fresenius Medical Care) analyzed by the following parameters: lean mass (LTM) (kg), fat mass (ATM) (kg) and water overload (OH) (L)	Day 150
Nutritional status	- Total energy intake (average of the 3 food survey days, kcal/day);	During the week preceding Day 150
Nutritional status	- Protein consumption (average of the 3 food survey days, g/day)	During the week preceding Day 150
Muscular force	Evaluated by the gripping force by dynamometry (kg)	Day 150
Acceptability of Renoral®	Self-administered questionnaire 4 questions: Overall, do you like this product? minimum score:1 (I don't like); maximum score: 9 (I like a lot); How do you find the texture of the product? Score 1: Not at all pleasant Score 2: Somewhat unpleasant Score 3: Somewhat pleasant Score 4: Very pleasant; What do you think of the practicality of the product? Score 1 - Not practical at all Score 2 - Not very practical Score 3 - Somewhat practical Score 4 - Very practical; What do you think of the vanilla flavour of the product? Score 1 - Much too pronounced Score 2 - Somewhat pronounced Score 3 - Just the right way Score 4 - Not strong enough Score 5 - Really not pronounced	Day 60 and Day 150

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (mmHg)	Security parameters evaluated from Day 0 to Day 150	Day 0 to Day 150 at time 0, 60, 120 and 240 minutes of dialysis
Blood count	Security parameters evaluated at all visits (from Day 0 to Day 150)	Day 0 to Day 150 at time 0 minute
Blood sugar	Security parameters evaluated at all visits (from V0 to V5)	Day 0 to Day 150 at time 0 minute
Electrolyte balance by ionogram. Blood ionogram expressed in (mmol.L-1), the parameters considered are: Sodium, Potassium, Chlorine, Bicarbonates, Calcium, and Phosphorus.	Security parameters evaluated at all visits (from V0 to V5)	Day 0 to Day 150 at time 0 minute
Liver function (Alkaline Phosphatase concentration)	Security parameters evaluated at all visits (from V0 to V5)	Day 0 to Day 150 at time 0 minute
Thyroid function (PTH concentration)	Security parameters evaluated at all visits (from V0 to V5)	Day 0 to Day 150 at time 0 minute

Collaborators and Investigators

• Sponsor: Indigo Therapeutics
• Collaborators: BioFortis
• Investigators: Principal Investigator: RAYMOND AZAR, MD, HOSPITAL CENTER DUNKERQUE

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: ID-RCB 2018-00145-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No