Actively Recruiting
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
Led by Dr. Schär AG / SPA · Updated on 2025-01-29
244
Participants Needed
21
Research Sites
173 weeks
Total Duration
On this page
Sponsors
D
Dr. Schär AG / SPA
Lead Sponsor
S
Slb Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CKD patient stage 3a-5 (estimated glomerular filtration rate less than 60 ml/min/1.73 m2) and not on dialysis
- Good nutritional status without signs of malnutrition based on albumin, pre-albumin, BMI, and clinical criteria
- Protein intake above 1 gram per kilogram of ideal body weight
- Not currently on a low-protein diet (LPD-na�efve)
- Motivated to start a low-protein diet and willing to follow dietary counseling and follow-up
- Able to attend scheduled visits and complete diet records and questionnaires
- Covered by a health insurance system or beneficiary
- Provided informed written consent to participate
You will not qualify if you...
- Planned or expected dialysis or transplantation within the next 12 months
- Known allergies to ingredients in FLAVIS products (milk, eggs, soy, nuts)
- Uncontrolled diabetes with HbA1C greater than 8.5%
- Active cancer or cancer remission less than 5 years
- Psychiatric disorders or inability to follow the study protocol
- Active infectious or uncontrolled inflammatory diseases
- Inability to provide blood samples due to poor veins
- Inability to perform accurate 24-hour urine collection
- Change in chronic medication within 1 month before screening
- Significant medical conditions or history affecting safety or study participation
- Presence of an active implanted medical device
- Participation in another clinical trial or within exclusion period of a previous trial
- Vulnerable subjects as defined by French public health code
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Clinique sainte isabelle
Abbeville, France, 80100
Actively Recruiting
2
Cabinet médical du Dr Magnant
Aix-en-Provence, France
Completed
3
CHU Besançon
Besançon, France
Actively Recruiting
4
Maison du Rein
Bordeaux, France
Actively Recruiting
5
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Actively Recruiting
6
CH Chalon
Chalon-sur-Saône, France
Actively Recruiting
7
CHU Gabriel Montpied
Clermont-Ferrand, France
Actively Recruiting
8
Santélys BFC
Dijon, France
Withdrawn
9
CH Le Mans
Le Mans, France
Actively Recruiting
10
Hospices Civiles de Lyon
Lyon, France
Actively Recruiting
11
Hôpital Edouard Heriot
Lyon, France
Withdrawn
12
Saint Joseph Saint Luc
Lyon, France
Actively Recruiting
13
Hôpital la conception
Marseille, France
Actively Recruiting
14
CH Mâcon
Mâcon, France
Actively Recruiting
15
APHP - Hôpital Necker
Paris, France
Not Yet Recruiting
16
AURA Paris
Paris, France
Withdrawn
17
Tenon hospital -APHP
Paris, France
Terminated
18
Hôpital Drôme Nord
Romans-sur-Isère, France
Actively Recruiting
19
Nouvel Hôpital Civil
Strasbourg, France
Not Yet Recruiting
20
Calydial
Vienne, France
Actively Recruiting
21
Hôpital Nord-Ouest
Villefranche-sur-Saône, France
Actively Recruiting
Research Team
V
Vinciane Dumay
CONTACT
O
Ophélie Flageul
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here