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

End Stage Renal Disease on Dialysis (Diagnosis) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03807583
• Other study ID #: ID-RCB 2018-00145-50
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: July 2020

Study information

• Verified date: March 2019
• Source: Indigo Therapeutics
• Contact: RAYMOND AZAR, MD
• Phone: +333 28 28 53 28
• Email: Raymond.Azar[@]ch-dunkerque.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis (Diagnosis)
• Kidney Failure, Chronic

Intervention

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.

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.

Locations

Country	Name	City	State
France	Hopital Center	Dunkerque

Sponsors (2)

Lead Sponsor	Collaborator
Indigo Therapeutics	BioFortis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Blood count	Security parameters evaluated at all visits (from Day 0 to Day 150)	Day 0 to Day 150 at time 0 minute
Other	Blood sugar	Security parameters evaluated at all visits (from V0 to V5)	Day 0 to Day 150 at time 0 minute
Other	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
Other	Liver function (Alkaline Phosphatase concentration)	Security parameters evaluated at all visits (from V0 to V5)	Day 0 to Day 150 at time 0 minute
Other	Thyroid function (PTH concentration)	Security parameters evaluated at all visits (from V0 to V5)	Day 0 to Day 150 at time 0 minute
Primary	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	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
Secondary	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
Secondary	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
Secondary	Protein catabolism	Plasma urea concentration (mmol.L-1) ;	Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Secondary	Protein catabolism	Plasma creatinine concentration (µmol.L-1);	Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Secondary	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
Secondary	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
Secondary	Nutritional status	Plasma albumin concentration (g.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Secondary	Nutritional status	- Plasma prealbumin concentration (g.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Secondary	Nutritional status	- Plasma ferritin concentration (µg.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Secondary	Nutritional status	- Plasma transferrin concentration (ng.L-1) ;	Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Secondary	Nutritional status	- Body mass index (BMI) (kg/m2)	Day 150
Secondary	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
Secondary	Nutritional status	- Total energy intake (average of the 3 food survey days, kcal/day);	During the week preceding Day 150
Secondary	Nutritional status	- Protein consumption (average of the 3 food survey days, g/day)	During the week preceding Day 150
Secondary	Muscular force	Evaluated by the gripping force by dynamometry (kg)	Day 150
Secondary	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