Back to resultsLow-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
Primary Purpose
Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Consumption of FLAVIS
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease Stage 3B focused on measuring low-protein diet, low-protein foods, FLAVIS, compliance, effectiveness, safety
Eligibility Criteria
Inclusion Criteria:
- CKD patient stage 3b-5 (<45 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,
- With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),
- Above 1g protein/ kg bw (ideal body weight),
- LPD-naïve patient,
- Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),
- Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),
- Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),
- Having given their informed written consent regarding its participation to the protocol.
Exclusion Criteria:
- Patient for whom dialysis or transplantation is planned/expected within the next 12 months
- Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),
- Diabetis mellitus (Type I and 2 defined as fasted glycemia > 1 .26 g/L or HbA1C >7% or anti-diabetic treatment),
- Active cancer,
- Psychiatric disorders or inability to follow the protocol,
- Evidence of any active infectious or inflammatory diseases,
- Inability to provide blood samples (poor venous capital),
- Inability to perform correct 24-hours urine collection,
- Any change of the chronic medication within 1 month before screening,
- Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
- Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.
- Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.
Sites / Locations
- Cabinet médical du Dr MagnantRecruiting
- CHU BesançonRecruiting
- Maison du ReinRecruiting
- CH ChalonRecruiting
- CHU Gabriel MontpiedRecruiting
- CH Le MansRecruiting
- Hospices Civiles de LyonRecruiting
- Hôpital la conceptionRecruiting
- CH MâconRecruiting
- AURA ParisRecruiting
- Tenon hospital -APHPRecruiting
- Hôpital Nord-OuestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
COMPARATOR
FLAVIS
Arm Description
Follow-up of the CKD patient according to current practice i.e. low protein diet.
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Protein intake during the 12 months follow-up
Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25
Dietary adherence
3-day dietary record correlated to a 24-hour urine collection
Dietary compliance for products under study
quantities consumed of FLAVIS products.
Effects of the LPD on BMI
weight and height will be combined to report BMI in kg/m^2
Effects of the LPD on weight
Weight in kg
Effects of the LPD on body composition: water
Water in litres
Effects of the LPD on body composition: muscles
Muscles in Kg
Effects of the LPD on body composition: body protein content
Body protein content in Kg
Effects of the LPD on Blood
Blood Chemistry
Effects of the LPD on Urine
Urine Chemistry
Incidence of Adverse Events [Safety of the LPD]
Questioning and a clinical examination; 4-point Likert scale.
Patient quality of life
SF-36 questionnaire score which from 0 to 100
Patient satisfaction with LPD
Auto-questionnaire, open questions
Full Information
NCT ID
NCT05489120
First Posted
August 1, 2022
Last Updated
September 6, 2023
Sponsor
Dr. Schär AG / SPA
Collaborators
Slb Pharma
1. Study Identification
Unique Protocol Identification Number
NCT05489120
Brief Title
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
Official Title
Randomized Controlled Trial of a Low-Protein Diet (LPD) With Low-Protein (LP) Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD): Efficacy and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Schär AG / SPA
Collaborators
Slb Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
Keywords
low-protein diet, low-protein foods, FLAVIS, compliance, effectiveness, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
COMPARATOR
Arm Type
No Intervention
Arm Description
Follow-up of the CKD patient according to current practice i.e. low protein diet.
Arm Title
FLAVIS
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Consumption of FLAVIS
Intervention Description
Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.
Primary Outcome Measure Information:
Title
Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)
Description
Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Protein intake during the 12 months follow-up
Description
Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25
Time Frame
1 month, 3 month, 6 month and 9 month
Title
Dietary adherence
Description
3-day dietary record correlated to a 24-hour urine collection
Time Frame
baseline, 1 month, 3 month, 6 month and 12 month
Title
Dietary compliance for products under study
Description
quantities consumed of FLAVIS products.
Time Frame
monthly up to 12 months
Title
Effects of the LPD on BMI
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
baseline, 1 month, 3 month, 6 month and 12 month
Title
Effects of the LPD on weight
Description
Weight in kg
Time Frame
baseline, 1 month, 3 month, 6 month and 12 month
Title
Effects of the LPD on body composition: water
Description
Water in litres
Time Frame
baseline, 1 month, 3 month, 6 month and 12 month
Title
Effects of the LPD on body composition: muscles
Description
Muscles in Kg
Time Frame
baseline, 1 month, 3 month, 6 month and 12 month
Title
Effects of the LPD on body composition: body protein content
Description
Body protein content in Kg
Time Frame
baseline, 1 month, 3 month, 6 month and 12 month
Title
Effects of the LPD on Blood
Description
Blood Chemistry
Time Frame
baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Title
Effects of the LPD on Urine
Description
Urine Chemistry
Time Frame
baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Title
Incidence of Adverse Events [Safety of the LPD]
Description
Questioning and a clinical examination; 4-point Likert scale.
Time Frame
3 month, 6 month and 12 month
Title
Patient quality of life
Description
SF-36 questionnaire score which from 0 to 100
Time Frame
baseline, 3 month, 6 month and 12 month
Title
Patient satisfaction with LPD
Description
Auto-questionnaire, open questions
Time Frame
3 month, 6 month and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CKD patient stage 3b-5 (<45 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,
With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),
Above 1g protein/ kg bw (ideal body weight),
LPD-naïve patient,
Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),
Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),
Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),
Having given their informed written consent regarding its participation to the protocol.
Exclusion Criteria:
Patient for whom dialysis or transplantation is planned/expected within the next 12 months
Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),
Diabetis mellitus (Type I and 2 defined as fasted glycemia > 1 .26 g/L or HbA1C >7% or anti-diabetic treatment),
Active cancer,
Psychiatric disorders or inability to follow the protocol,
Evidence of any active infectious or inflammatory diseases,
Inability to provide blood samples (poor venous capital),
Inability to perform correct 24-hours urine collection,
Any change of the chronic medication within 1 month before screening,
Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.
Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Cameli
Phone
0299121962
Ext
+33
Email
c.cameli@slbpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ophélie Flageul
Phone
0299121962
Ext
+33
Email
o.flageul@slbpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laetitia Koppe, Dr
Organizational Affiliation
HCL
Official's Role
Study Director
Facility Information:
Facility Name
Cabinet médical du Dr Magnant
City
Aix-en-Provence
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Magnant, Dr
Facility Name
CHU Besançon
City
Besançon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Courivaud, Dr
Facility Name
Maison du Rein
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Chauveau, Dr
Facility Name
CH Chalon
City
Chalon-sur-Saône
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayman Abokasem, Dr
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Elisabeth Heng, Pr
Facility Name
CH Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giorgina PICCOLI, Pr
Facility Name
Hospices Civiles de Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia Koppe, Dr
Facility Name
Hôpital la conception
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Burtey, Pr
Facility Name
CH Mâcon
City
Mâcon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allyriane Chartier-Dantec, Dr
Facility Name
AURA Paris
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Kolko-Labadens, Dr
Facility Name
Tenon hospital -APHP
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafedh Fessi, Dr
Facility Name
Hôpital Nord-Ouest
City
Villefranche-sur-Saône
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile Teuma, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
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