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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807583
Recruitment Status : Unknown
Verified March 2019 by Indigo Therapeutics.
Recruitment status was:  Recruiting
First Posted : January 17, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
BioFortis
Information provided by (Responsible Party):
Indigo Therapeutics

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease on Dialysis (Diagnosis) Drug: Aminoven 10% Dietary Supplement: RENORAL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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.





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


Secondary Outcome Measures :
  1. Plasma total amino acid concentration [ Time Frame: Day 60; Time 240 minutes of kinetics ]
    Comparison between the RENORAL® group and the plasma total amino acid concentration control group

  2. Plasma total amino acid concentration [ Time Frame: Time 0 minutes, Time 60 minutes and Time 120 minutes of kinetics ]
    Comparison between the RENORAL® group and each AMINOVEN® group and control

  3. Plasma total amino acid concentration [ Time Frame: Day 90; Day 120 and Day 150 at time 240 minutes of kinetics ]
    Comparison between the RENORAL® group and each AMINOVEN® group and control

  4. Protein catabolism [ Time Frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics ]
    Plasma urea concentration (mmol.L-1) ;

  5. Protein catabolism [ Time Frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics ]
    Plasma creatinine concentration (µmol.L-1);

  6. Protein catabolism [ Time Frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics ]

    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)


  7. Inflammation degree [ Time Frame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics ]
    Comparison between the RENORAL® group and each AMINOVEN® group and control. Evaluated by plasma CRPus concentration (mg.L-1).

  8. Nutritional status [ Time Frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics ]
    Plasma albumin concentration (g.L-1) ;

  9. Nutritional status [ Time Frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics ]
    - Plasma prealbumin concentration (g.L-1) ;

  10. Nutritional status [ Time Frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics ]
    - Plasma ferritin concentration (µg.L-1) ;

  11. Nutritional status [ Time Frame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics ]
    - Plasma transferrin concentration (ng.L-1) ;

  12. Nutritional status [ Time Frame: Day 150 ]
    - Body mass index (BMI) (kg/m2)

  13. Nutritional status [ Time Frame: Day 150 ]
    - 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)

  14. Nutritional status [ Time Frame: During the week preceding Day 150 ]
    - Total energy intake (average of the 3 food survey days, kcal/day);

  15. Nutritional status [ Time Frame: During the week preceding Day 150 ]
    - Protein consumption (average of the 3 food survey days, g/day)

  16. Muscular force [ Time Frame: Day 150 ]
    Evaluated by the gripping force by dynamometry (kg)

  17. Acceptability of Renoral® [ Time Frame: Day 60 and Day 150 ]

    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


Other Outcome Measures:
  1. Blood pressure (mmHg) [ Time Frame: Day 0 to Day 150 at time 0, 60, 120 and 240 minutes of dialysis ]
    Security parameters evaluated from Day 0 to Day 150

  2. Blood count [ Time Frame: Day 0 to Day 150 at time 0 minute ]
    Security parameters evaluated at all visits (from Day 0 to Day 150)

  3. Blood sugar [ Time Frame: Day 0 to Day 150 at time 0 minute ]
    Security parameters evaluated at all visits (from V0 to V5)

  4. Electrolyte balance by ionogram. Blood ionogram expressed in (mmol.L-1), the parameters considered are: Sodium, Potassium, Chlorine, Bicarbonates, Calcium, and Phosphorus. [ Time Frame: Day 0 to Day 150 at time 0 minute ]
    Security parameters evaluated at all visits (from V0 to V5)

  5. Liver function (Alkaline Phosphatase concentration) [ Time Frame: Day 0 to Day 150 at time 0 minute ]
    Security parameters evaluated at all visits (from V0 to V5)

  6. Thyroid function (PTH concentration) [ Time Frame: Day 0 to Day 150 at time 0 minute ]
    Security parameters evaluated at all visits (from V0 to V5)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807583


Contacts
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Contact: RAYMOND AZAR, MD +333 28 28 53 28 Raymond.Azar@ch-dunkerque.fr
Contact: FAHIMA YAHI +333 28 28 59 00 ext 6486 Fahima.Yahi-Zidat@ch-dunkerque.fr

Locations
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France
Hopital Center Recruiting
Dunkerque, France, 59240
Contact: FAHIMA YAHI    +333 28 28 59 00 ext 6486    Fahima.Yahi-Zidat@ch-dunkerque.fr   
Sponsors and Collaborators
Indigo Therapeutics
BioFortis
Investigators
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Principal Investigator: RAYMOND AZAR, MD HOSPITAL CENTER DUNKERQUE
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Responsible Party: Indigo Therapeutics
ClinicalTrials.gov Identifier: NCT03807583    
Other Study ID Numbers: ID-RCB 2018-00145-50
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency