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Clinical Trial Details

Trial ID: L0515
Source ID: NCT03807583
Associated Drug: Aminoven 10%
Title: Plasma Amino Acid Levels After Protein Ingestion or Amino Acid Injection During Dialysis
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: End Stage Renal Disease on Dialysis (Diagnosis)
Interventions: DRUG: Aminoven 10%|DIETARY_SUPPLEMENT: RENORAL
Outcome Measures: 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|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: 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
Sponsor/Collaborators: Sponsor: Indigo Therapeutics | Collaborators: BioFortis
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2019-03-15
Completion Date: 2020-07
Results First Posted:
Last Update Posted: 2019-03-19
Locations: Hopital Center, Dunkerque, 59240, France
URL: https://clinicaltrials.gov/show/NCT03807583