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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMPARATOR | No Intervention | Follow-up of the CKD patient according to current practice i.e. low protein diet. | |
| FLAVIS | Experimental | Follow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consumption of FLAVIS | Other | Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods) | Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25 | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Protein intake during the 12 months follow-up | Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25 | 1 month, 3 month, 6 month and 9 month |
| Dietary adherence | 3-day dietary record correlated to a 24-hour urine collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vinciane Dumay | Contact | 0756917356 | +33 | v.dumay@slbpharma.com |
| Ophélie Flageul | Contact | 0299121962 | +33 | o.flageul@slbpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Laetitia Koppe, Dr | HCL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique sainte isabelle | Recruiting | Abbeville | 80100 | France |
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| baseline, 1 month, 3 month, 6 month and 12 month |
| Dietary compliance for products under study | quantities consumed of FLAVIS products. | monthly up to 12 months |
| Effects of the LPD on BMI | Weight and height will be combined to report BMI in kg/m^2. | baseline, 1 month, 3 month, 6 month and 12 month |
| Effects of the LPD on weight | Weight in kg | baseline, 1 month, 3 month, 6 month and 12 month |
| Effects of the LPD on body composition: water | Water in litres | baseline, 1 month, 3 month, 6 month and 12 month |
| Effects of the LPD on body composition: muscles | Muscles in Kg | baseline, 1 month, 3 month, 6 month and 12 month |
| Effects of the LPD on body composition: body protein content | Body protein content in Kg | baseline, 1 month, 3 month, 6 month and 12 month |
| Effects of the LPD on Blood | Blood Chemistry | baseline, 1 month, 3 month, 6 month, 9 month and 12 month |
| Effects of the LPD on Urine | Urine Chemistry | baseline, 1 month, 3 month, 6 month, 9 month and 12 month |
| Effects of the LPD on diabetic patient glycemic profile | Hb1Ac will be measured | Baseline, 6 month and 12 month |
| Incidence of Adverse Events [Safety of the LPD] | Questioning and a clinical examination, biological analyses review | 1 month, 3 month, 6 month, 9 month and 12 month |
| Incidence of Adverse Events [Safety of the LPD] | 4-points Likert scale | 3 month, 6 month and 12 month |
| Patient quality of life | SF-36 questionnaire score which from 0 to 100 | baseline, 3 month, 6 month and 12 month |
| Patient satisfaction with LPD | Auto-questionnaire with numerical scales, closed-ended questions and Likert scales | 3 month, 6 month and 12 month |
| Cabinet médical du Dr Magnant | Completed | Aix-en-Provence | France |
| CHU Besançon | Recruiting | Besançon | France |
|
| Maison du Rein | Recruiting | Bordeaux | France |
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| Polyclinique Bordeaux Nord Aquitaine | Recruiting | Bordeaux | France |
|
| CH Chalon | Recruiting | Chalon-sur-Saône | France |
|
| CHU Gabriel Montpied | Recruiting | Clermont-Ferrand | France |
|
| Santélys BFC | Withdrawn | Dijon | France |
| CH Le Mans | Recruiting | Le Mans | France |
|
| Hospices Civiles de Lyon | Recruiting | Lyon | France |
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| Hôpital Edouard Heriot | Withdrawn | Lyon | France |
| Saint Joseph Saint Luc | Recruiting | Lyon | France |
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| Hôpital la conception | Recruiting | Marseille | France |
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| CH Mâcon | Recruiting | Mâcon | France |
|
| APHP - Hôpital Necker | Not yet recruiting | Paris | France |
|
| AURA Paris | Withdrawn | Paris | France |
| Tenon hospital -APHP | Terminated | Paris | France |
| Hôpital Drôme Nord | Recruiting | Romans-sur-Isère | France |
|
| Nouvel Hôpital Civil | Not yet recruiting | Strasbourg | France |
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| Calydial | Recruiting | Vienne | France |
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| Hôpital Nord-Ouest | Recruiting | Villefranche-sur-Saône | France |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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