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| Name | Class |
|---|---|
| BioFortis | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | ||
| AMINOVEN® 10% | Active Comparator | 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. |
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| RENORAL® | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminoven 10% | Drug | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RAYMOND AZAR, MD | Contact | +333 28 28 53 28 | Raymond.Azar@ch-dunkerque.fr | |
| FAHIMA YAHI | Contact | +333 28 28 59 00 | 6486 | Fahima.Yahi-Zidat@ch-dunkerque.fr |
| Name | Affiliation | Role |
|---|---|---|
| RAYMOND AZAR, MD | HOSPITAL CENTER DUNKERQUE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Center | Recruiting | Dunkirk | 59240 | France |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This clinical study is a monocentric, randomized, open-label, 3 parallel arms, and controlled study.
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|
| RENORAL | Dietary Supplement | 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:
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. |
|
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):
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:
| Day 60 and 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 |