Chronic Kidney Disease Stage 3BNCT05489120
Low-Protein Diet With Low-Protein Foods Versus a LPD Without LP Foods in Patients With Chronic Kidney Disease (CKD)
A study testing Consumption of FLAVIS in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Dr. Schär AG / SPA at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5
- What is being tested?
- Consumption of FLAVIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 18 sitesFrance
- Study dates
- 6 Nov 2022to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD patient stage 3a-5 (<60 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.
Who cannot join
- 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),
- Uncontrolled Diabetes (HbA1C >8.5%),
- Active cancer (including a 5 years remission period),
- Psychiatric disorders or inability to follow the protocol,
- Evidence of any active infectious or uncontrolled inflammatory diseases,
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- 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,
- Patient with an active implanted medical device
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Clinique sainte isabelle
Abbeville, 80100
Cabinet médical du Dr Magnant
Aix-en-Provence
CHU Besançon
Besançon
Maison du Rein
Bordeaux
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
CH Chalon
Chalon-sur-Saône
CHU Gabriel Montpied
Clermont-Ferrand
CH Le Mans
Le Mans
Hospices Civiles de Lyon
Lyon
Saint Joseph Saint Luc
Lyon
CH Mâcon
Mâcon
Hôpital la conception
Marseille
APHP - Hôpital Necker
Paris
Tenon hospital -APHP
Paris
Hôpital Drôme Nord
Romans-sur-Isère
Nouvel Hôpital Civil
Strasbourg
Calydial
Vienne
Hôpital Nord-Ouest
Villefranche-sur-Saône
About this study
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
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
- Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 3A
- Being tested
- Consumption of FLAVIS
- Keywords
- low-protein diet, low-protein foods, FLAVIS, compliance, effectiveness, safety
- Medical subject headings
- Renal Insufficiency, Chronic, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of FLAVISOther
Patients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Consumption of FLAVIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 month
Secondary outcomes (15)
Protein intake during the 12 months follow-up
Maroni formula: (Measurement of urea in urine + ([patient weight]*0.031))*6.25
Measured: 1 month, 3 month, 6 month and 9 month
Dietary adherence
3-day dietary record correlated to a 24-hour urine collection
Measured: baseline, 1 month, 3 month, 6 month and 12 month
Dietary compliance for products under study
quantities consumed of FLAVIS products.
Measured: monthly up to 12 months
Effects of the LPD on BMI
Weight and height will be combined to report BMI in kg/m^2.
Measured: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on weight
Weight in kg
Measured: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: water
Water in litres
Measured: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: muscles
Muscles in Kg
Measured: 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
Measured: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on Blood
Blood Chemistry
Measured: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on Urine
Urine Chemistry
Measured: 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
Measured: Baseline, 6 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Questioning and a clinical examination, biological analyses review
Measured: 1 month, 3 month, 6 month, 9 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
4-points Likert scale
Measured: 3 month, 6 month and 12 month
Patient quality of life
SF-36 questionnaire score which from 0 to 100
Measured: baseline, 3 month, 6 month and 12 month
Patient satisfaction with LPD
Auto-questionnaire with numerical scales, closed-ended questions and Likert scales
Measured: 3 month, 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start6 Nov 2022
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 3BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Schär AG / SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Laetitia Koppe, Dr, Study director, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489120
- Sponsor's protocol ID
- EFFLAVIS
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05489120
- Acronym / sponsor ID
- EFFLAVIS
- Conditions
- Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 3A
- Keywords
- low-protein diet, low-protein foods, FLAVIS, compliance, effectiveness, safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Dr. Schär AG / SPAIndustry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Study start
- 6 Nov 2022 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMPARATOR | No intervention | –Follow-up of the CKD patient according to current practice i.e. low protein diet. |
| FLAVIS | Experimental | Other: Consumption of FLAVISFollow-up of the CKD patient according to the current practice i.e. low protein diet with the addition of of low-protein products (FLAVIS). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- CKD patient stage 3a-5 (<60 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),
Key exclusion criteria (13 listed)
- 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),
- Uncontrolled Diabetes (HbA1C >8.5%),
- Active cancer (including a 5 years remission period),
- Psychiatric disorders or inability to follow the protocol,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumption of FLAVISPatients of the FLAVIS group will recevied FLAVIS products in addition to their diet follow-up. | Other | FLAVIS |
Primary outcome
Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods)
Time frame: 12 month
Maroni formula : (Measurement of urea in urine + ([patient weight]*0.031))*6.25
15 secondary outcomes
Protein intake during the 12 months follow-up
Time frame: 1 month, 3 month, 6 month and 9 month
Dietary adherence
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Dietary compliance for products under study
Time frame: monthly up to 12 months
Effects of the LPD on BMI
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on weight
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: water
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: muscles
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on body composition: body protein content
Time frame: baseline, 1 month, 3 month, 6 month and 12 month
Effects of the LPD on Blood
Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on Urine
Time frame: baseline, 1 month, 3 month, 6 month, 9 month and 12 month
Effects of the LPD on diabetic patient glycemic profile
Time frame: Baseline, 6 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Time frame: 1 month, 3 month, 6 month, 9 month and 12 month
Incidence of Adverse Events [Safety of the LPD]
Time frame: 3 month, 6 month and 12 month
Patient quality of life
Time frame: baseline, 3 month, 6 month and 12 month
Patient satisfaction with LPD
Time frame: 3 month, 6 month and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laetitia Koppe, Dr study director
HCL
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of FLAVIS in people with Chronic Kidney Disease Stage 3B and Chronic Kidney Disease stage4, run by Dr. Schär AG / SPA at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness in terms of protein intake of a LPD with LP foods (FLAVIS products) compared to standard products (LPD without consumption of LP foods) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.