Clinical trial NCT03807583: 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
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease on Dialysis (Diagnosis)
Lead sponsor: Indigo Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2019-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Plasma total amino acid concentration
timeFrame: Day 60; Time 240 minutes of the kinetic
Secondary outcomes:
measure: Plasma total amino acid concentration
timeFrame: Day 60; Time 240 minutes of kinetics
measure: Plasma total amino acid concentration
timeFrame: Time 0 minutes, Time 60 minutes and Time 120 minutes of kinetics
measure: Plasma total amino acid concentration
timeFrame: Day 90; Day 120 and Day 150 at time 240 minutes of kinetics
measure: Protein catabolism
timeFrame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
measure: Protein catabolism
timeFrame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
measure: Protein catabolism
timeFrame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
measure: Inflammation degree
timeFrame: Day 90; Day 120 and Day 150 at time 0 minutes of kinetics
measure: Nutritional status
timeFrame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
measure: Nutritional status
timeFrame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
measure: Nutritional status
timeFrame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
measure: Nutritional status
timeFrame: Day 90, Day 120 and Day 150; At time 0 minute of kinetics
measure: Nutritional status
timeFrame: Day 150
measure: Nutritional status
timeFrame: Day 150
measure: Nutritional status
timeFrame: During the week preceding Day 150
measure: Nutritional status
timeFrame: During the week preceding Day 150
measure: Muscular force
timeFrame: Day 150
measure: Acceptability of Renoral®
timeFrame: Day 60 and Day 150
Other outcomes:
measure: Blood pressure (mmHg)
timeFrame: Day 0 to Day 150 at time 0, 60, 120 and 240 minutes of dialysis
measure: Blood count
timeFrame: Day 0 to Day 150 at time 0 minute
measure: Blood sugar
timeFrame: Day 0 to Day 150 at time 0 minute
measure: Electrolyte balance by ionogram. Blood ionogram expressed in (mmol.L-1), the parameters considered are: Sodium, Potassium, Chlorine, Bicarbonates, Calcium, and Phosphorus.
timeFrame: Day 0 to Day 150 at time 0 minute
measure: Liver function (Alkaline Phosphatase concentration)
timeFrame: Day 0 to Day 150 at time 0 minute
measure: Thyroid function (PTH concentration)
timeFrame: Day 0 to Day 150 at time 0 minute
Locations:
city: Dunkerque
country: France
facility: Hopital Center
Study officials:
affiliation: HOSPITAL CENTER DUNKERQUE
name: RAYMOND AZAR, MD
role: PRINCIPAL_INVESTIGATOR
References: