Back to resultsPlasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
Primary Purpose
End Stage Renal Disease on Dialysis (Diagnosis)
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Aminoven 10%
RENORAL
Sponsored by
About this trial
This is an interventional prevention trial for End Stage Renal Disease on Dialysis (Diagnosis)
Eligibility 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.
Sites / Locations
- Hopital CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Control group
AMINOVEN® 10%
RENORAL®
Arm 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.
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.
Outcomes
Primary Outcome Measures
Plasma total amino acid concentration
The efficacy of the test product will be evaluated by comparing this criterion between the RENORAL® and AMINOVEN® groups.
Secondary Outcome Measures
Plasma total amino acid concentration
Comparison between the RENORAL® group and the plasma total amino acid concentration control group
Plasma total amino acid concentration
Comparison between the RENORAL® group and each AMINOVEN® group and control
Plasma total amino acid concentration
Comparison between the RENORAL® group and each AMINOVEN® group and control
Protein catabolism
Plasma urea concentration (mmol.L-1) ;
Protein catabolism
Plasma creatinine concentration (µmol.L-1);
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)
Inflammation degree
Comparison between the RENORAL® group and each AMINOVEN® group and control. Evaluated by plasma CRPus concentration (mg.L-1).
Nutritional status
Plasma albumin concentration (g.L-1) ;
Nutritional status
- Plasma prealbumin concentration (g.L-1) ;
Nutritional status
- Plasma ferritin concentration (µg.L-1) ;
Nutritional status
- Plasma transferrin concentration (ng.L-1) ;
Nutritional status
- Body mass index (BMI) (kg/m2)
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)
Nutritional status
- Total energy intake (average of the 3 food survey days, kcal/day);
Nutritional status
- Protein consumption (average of the 3 food survey days, g/day)
Muscular force
Evaluated by the gripping force by dynamometry (kg)
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
Full Information
NCT ID
NCT03807583
First Posted
December 27, 2018
Last Updated
March 18, 2019
Sponsor
Indigo Therapeutics
Collaborators
BioFortis
1. Study Identification
Unique Protocol Identification Number
NCT03807583
Brief Title
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indigo Therapeutics
Collaborators
BioFortis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis (Diagnosis)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Title
AMINOVEN® 10%
Arm Type
Active Comparator
Arm 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.
Arm Title
RENORAL®
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Aminoven 10%
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
RENORAL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma total amino acid concentration
Description
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 Outcome Measure Information:
Title
Plasma total amino acid concentration
Description
Comparison between the RENORAL® group and the plasma total amino acid concentration control group
Time Frame
Day 60; Time 240 minutes of kinetics
Title
Plasma total amino acid concentration
Description
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
Title
Plasma total amino acid concentration
Description
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
Title
Protein catabolism
Description
Plasma urea concentration (mmol.L-1) ;
Time Frame
Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Title
Protein catabolism
Description
Plasma creatinine concentration (µmol.L-1);
Time Frame
Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Title
Protein catabolism
Description
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)
Time Frame
Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Title
Inflammation degree
Description
Comparison between the RENORAL® group and each AMINOVEN® group and control. Evaluated by plasma CRPus concentration (mg.L-1).
Time Frame
Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
Title
Nutritional status
Description
Plasma albumin concentration (g.L-1) ;
Time Frame
Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Title
Nutritional status
Description
- Plasma prealbumin concentration (g.L-1) ;
Time Frame
Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Title
Nutritional status
Description
- Plasma ferritin concentration (µg.L-1) ;
Time Frame
Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Title
Nutritional status
Description
- Plasma transferrin concentration (ng.L-1) ;
Time Frame
Day 90, Day 120 and Day 150; At time 0 minute of kinetics
Title
Nutritional status
Description
- Body mass index (BMI) (kg/m2)
Time Frame
Day 150
Title
Nutritional status
Description
- 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)
Time Frame
Day 150
Title
Nutritional status
Description
- Total energy intake (average of the 3 food survey days, kcal/day);
Time Frame
During the week preceding Day 150
Title
Nutritional status
Description
- Protein consumption (average of the 3 food survey days, g/day)
Time Frame
During the week preceding Day 150
Title
Muscular force
Description
Evaluated by the gripping force by dynamometry (kg)
Time Frame
Day 150
Title
Acceptability of Renoral®
Description
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
Time Frame
Day 60 and Day 150
Other Pre-specified Outcome Measures:
Title
Blood pressure (mmHg)
Description
Security parameters evaluated from Day 0 to Day 150
Time Frame
Day 0 to Day 150 at time 0, 60, 120 and 240 minutes of dialysis
Title
Blood count
Description
Security parameters evaluated at all visits (from Day 0 to Day 150)
Time Frame
Day 0 to Day 150 at time 0 minute
Title
Blood sugar
Description
Security parameters evaluated at all visits (from V0 to V5)
Time Frame
Day 0 to Day 150 at time 0 minute
Title
Electrolyte balance by ionogram. Blood ionogram expressed in (mmol.L-1), the parameters considered are: Sodium, Potassium, Chlorine, Bicarbonates, Calcium, and Phosphorus.
Description
Security parameters evaluated at all visits (from V0 to V5)
Time Frame
Day 0 to Day 150 at time 0 minute
Title
Liver function (Alkaline Phosphatase concentration)
Description
Security parameters evaluated at all visits (from V0 to V5)
Time Frame
Day 0 to Day 150 at time 0 minute
Title
Thyroid function (PTH concentration)
Description
Security parameters evaluated at all visits (from V0 to V5)
Time Frame
Day 0 to Day 150 at time 0 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAYMOND AZAR, MD
Phone
+333 28 28 53 28
Email
Raymond.Azar@ch-dunkerque.fr
First Name & Middle Initial & Last Name or Official Title & Degree
FAHIMA YAHI
Phone
+333 28 28 59 00
Ext
6486
Email
Fahima.Yahi-Zidat@ch-dunkerque.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAYMOND AZAR, MD
Organizational Affiliation
HOSPITAL CENTER DUNKERQUE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Center
City
Dunkerque
ZIP/Postal Code
59240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FAHIMA YAHI
Phone
+333 28 28 59 00
Ext
6486
Email
Fahima.Yahi-Zidat@ch-dunkerque.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
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