End Stage Renal Disease on Dialysis (Diagnosis)
Conditions
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.
Interventions
DRUGAminoven 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_SUPPLEMENTRENORAL
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.
Sponsors
BioFortis
Indigo Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma total amino acid concentration | 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
| Measure | Time frame | Description |
|---|---|---|
| Plasma total amino acid concentration | Day 60; Time 240 minutes of kinetics | Comparison between the RENORAL® group and the plasma total amino acid concentration control group |
| Protein catabolism | Day 90; Day 120 and Day 150 at time 0 minutes of kinetics | Plasma urea concentration (mmol.L-1) ; |
| Inflammation degree | 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). |
| Nutritional status | Day 90, Day 120 and Day 150; At time 0 minute of kinetics | Plasma albumin concentration (g.L-1) ; |
| Muscular force | Day 150 | Evaluated by the gripping force by dynamometry (kg) |
| Acceptability of Renoral® | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood sugar | Day 0 to Day 150 at time 0 minute | Security parameters evaluated at all visits (from V0 to V5) |
| Blood pressure (mmHg) | Day 0 to Day 150 at time 0, 60, 120 and 240 minutes of dialysis | Security parameters evaluated from Day 0 to Day 150 |
| Electrolyte balance by ionogram. Blood ionogram expressed in (mmol.L-1), the parameters considered are: Sodium, Potassium, Chlorine, Bicarbonates, Calcium, and Phosphorus. | Day 0 to Day 150 at time 0 minute | Security parameters evaluated at all visits (from V0 to V5) |
| Liver function (Alkaline Phosphatase concentration) | Day 0 to Day 150 at time 0 minute | Security parameters evaluated at all visits (from V0 to V5) |
| Thyroid function (PTH concentration) | Day 0 to Day 150 at time 0 minute | Security parameters evaluated at all visits (from V0 to V5) |
| Blood count | Day 0 to Day 150 at time 0 minute | Security parameters evaluated at all visits (from Day 0 to Day 150) |
Countries
France
Contacts
Primary ContactRAYMOND AZAR, MD
Backup ContactFAHIMA YAHI
Outcome results
None listed